[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,90,0,25,[9,46,68,112,153,192,266,307,328,355,385,408,432,453,480,499,521,545,568,592,629,691,721,744,773],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100527940","phase-1-fih-xon7-in-advancedmetastatic-solid-tumors-100527940",false,"NCT06154291","FIH XON7 in Advanced\u002FMetastatic Solid Tumors","Phase I\u002FII, Multi Center, Open Label, First-in-human, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-tumors Efficacy of the Glyco-humanized Polyclonal Antibody XON7 in Patients With Advanced or Metastatic Solid Tumors","FIPO23","Inclusion Criteria:\n\n1. Provide signed, written informed consent.\n2. Male and female participant, age ≥ 18 years old (at the time consent is obtained)\n3. Solid tumors indications:\n\n   * Participant in phase I, must have a histologically or cytologically confirmed advanced or metastatic solid tumors for which no effective standard therapy is available. All tumor types except glioblastoma, could be included.\n   * Participant in phase II, must have histologically or cytologically confirmed advanced or metastatic solid tumors of the following: NSCLC, gastro-esophageal adenocarcinoma, CRC, pancreatic cancer, Sarcoma, TNBC, or ovarian cancer.\n4. Line of treatment: Participant must have solid tumors progressing after ≤ 4 lines of standard appropriate anticancer therapies for the specific tumor type, or for which the patient is ineligible. Participants whose cancers harbor molecular alterations for which targeted therapy is standard of care should have received health authority-approved appropriate targeted therapy for their tumor types before enrollment.\n5. Measurable disease per RECIST version 1.1 - v5\n6. (ECOG) performance status (PS) 0-1\n7. Life expectancy of at least 12 weeks.\n8. Adequate organ function\n9. QT duration corrected for heart rate by Fridericia's formula (QTcF) \\\u003C450 msec or QTcF \\\u003C480 msec for participants with bundle branch block.\n10. In France, a participant will be eligible for inclusion in this trial only if either affiliated to or a beneficiary of a social security category.\n11. Female participant who are not of child-bearing potential, and female participants of child-bearing potential who have a negative serum pregnancy test within 7 days prior to initial trial treatment. Female participants of child-bearing potential, and all male partners must consent to use a medically acceptable method of contraception throughout the trial period and for at least 60 days after the last dose of XON7. A barrier method of contraception must be included.\n12. Male participant willing to use adequate contraceptive measures throughout the trial period and for at least 60 days after the last dose of trial intervention.\n13. For phase II, participant in pharmacodynamics cohort must provide biopsy of a tumor lesion not previously irradiated during the screening period and must agree to provide at least one additional on-treatment biopsy between day 36 and 42 after trial intervention administration.\n14. For phase II, participant in pharmacodynamics cohort must have accessible tumor tissue available for fresh biopsy except for ovarian cancer and sarcoma.\n\nExclusion Criteria:\n\n1. A participant who has received more than 4 prior lines of therapy for advanced or metastatic disease.\n2. A participant who has had a prior anti-cancer mAb within 3 weeks prior to trial Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier prior to trial Day 1.\n3. A participant who has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial Day 1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (Except alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with replacement therapy).\n4. A participant with ≥Grade 3 toxicity related to prior immunotherapy leading to treatment discontinuation.\n5. A participant whose toxicity related to prior treatment has not resolved to Grade 1 (except alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with replacement therapy).\n6. A participant who has received major surgery 2 weeks before the first dose of trial treatment or has not recovered adequately from the toxicity and\u002For complications from any surgery (major or minor) before initiating trial treatment.\n7. Concomitant use of another experimental drug, or wash-out period of at least 5 half-lives for a previous experimental drug not completed before start of trial intervention\n8. Participant treated with drugs known to prolong the QT interval\n9. Participant with carcinomatous meningitis.\n10. Central nervous system (CNS) metastases, with the exception of individuals who have been previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids for 3 weeks prior to first dose of trial drug.\n11. Malignancies other than disease under trial within 3 years prior to first dose of trial intervention.\n12. History of autoimmune disease\n13. Active or uncontrolled infections requiring systemic treatment (known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C).\n14. Any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation in the trial such as history or evidence of cardiovascular risk including any of the following:\n\n    * Recent (within the past 6 months) history of serious uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second degree (Type II) or third-degree atrioventricular block.\n    * Documented cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting within the past 6 months before enrollment.\n    * Documented congestive heart failure (Class II, III, or IV) as defined by the New York Heart Association functional classification system (NYHA, 1994).\n15. Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.\n16. Current active liver or biliary disease (Except for Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per investigator assessment).\n17. Concurrent medical condition requiring the use of systemic immunosuppressive medications within 28 days before the first dose of trial treatment.\n18. Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.\n19. Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia. Note: post-radiation changes in the lung related to prior radiotherapy and\u002For asymptomatic radiation-induced pneumonitis not requiring treatment may be permitted if agreed by the investigator and Medical Monitor.\n20. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n21. Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.\n22. Participant who has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony- stimulating factor \\[G-CSF\\], granulocyte-macrophage colony-stimulating factor \\[GM- CSF\\], recombinant erythropoietin) within 2 weeks before the first dose of trial intervention.\n23. Known, current drug or alcohol abuse.\n24. Female participant who is pregnant or lactating.\n25. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.\n26. Inability or unwillingness to comply with trial and\u002For follow-up procedures outlined in the protocol.\n27. For France, patients under legal protection (safeguard, guardianship, curatorship)","ALL","18 Years",{"count":21,"type":22},255,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This is a two-stage trial consisting of a Part I, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), if any, and Recommended Part 2 Dose (RP2D) of XON7, followed by a Part II component to investigate anti-tumors efficacy in selected solid tumor types and to further evaluate safety and tolerability of XON7 at RP2D.",[29,30],"Advanced Solid Tumor","Metastatic Cancer",[32],"Advanced or metastatic solid tumors","RECRUITING","2026-08-19",{"date":36,"type":37},"2026-08-20","ACTUAL",{"date":39,"type":37},"2023-11-14",{"date":41,"type":22},"2027-11",{"name":43,"class":44},"Xenothera SAS","INDUSTRY",5,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100608139","phase-1-y-nm600-in-patients-receiving-anti-pd-1-or-anti-pd-l1-for-metastatic-cancer-100608139","NCT07197671","Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 for Metastatic Cancer","Phase 1 Study of Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 Therapy for Metastatic Cancer","Inclusion Criteria:\n\n1. Participant must be informed of the investigational nature of the study and must be able to sign a written informed consent.\n2. Participants with histologically or cytologically confirmed squamous cell carcinoma thought to originate from the head and neck region (HNC).\n3. Participants must have metastatic solid malignancy, non-hematological.\n4. Participants must be under treatment with one of the following FDA-approved standard-of-care anti-PD-1 or anti-PD-L1 therapies: Pembrolizumab (Keytruda; anti-PD-1 antibody), Nivolumab (Opdivo; anti-PD-1 antibody), Atezolizumab (Tecentriq, anti-PD-L1 antibody), Avelumab (Bavencio; anti-PD-L1 antibody), Durvalumab (Imfinzi; anti-PD-L1 antibody), Cemiplimab (Libtayo; anti-PD-1 antibody), Dostarlimab (Jemperli; anti-PD-1 antibody). Participants may be on additional FDA-approved immunotherapy treatments including anti-CTLA4 therapies or anti-LAG-3 therapies in addition to the anti-PD-1 or anti-PD-L1 backbone therapy. The specific additional therapies allowed are: Ipilimumab (Yervoy; anti-CTLA4 antibody), Tremelimumab (Imjudo; anti-CTLA4 antibody), or Relatlimab (Opdualag; anti-LAG-3).\n5. Participants must have stable disease or concern for progression of their disease on most recent imaging scans yet be continuing on anti-PD1 or anti-PD-L1 therapy, per the treating physician. Participants may continue on anti-CTLA-4 or anti-LAG-3 ICIs if they have already been taking these when assessed to have stable or potentially progressive disease on most recent imaging. Subjects may also discontinue anti-CTLA-4 or anti-LAG-3 ICIs and remain eligible as long as they meet above criteria and continue the anti-PD-1 or anti-PD-L1 component of therapy that they have already been taking.\n6. Participants must have at least one evaluable (measurable) tumor that is radiographically detectable.\n7. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.\n8. Participants must have a life expectancy of at least 6 months.\n9. People who could become pregnant have a confirmed negative urine pregnancy test within 7 days prior to receiving Y-NM600.\n10. Participants who are not surgically or medically sterile must agree to use an acceptable method of contraception, such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence during the study participation and for 6 months after last dose of study drug. Participants who could impregnate their sexual partners must also abstain from intercourse for three weeks after Y-NM600 treatment and agree to use condoms at least 2 months after the last dose of this drug. Participants who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be people who could become pregnant.\n11. The participant has adequate renal function as defined by Cockcroft-Gault calculated creatinine clearance \\>40 ml\u002Fmin\n12. The subject has adequate hepatic function as defined by:\n\n    1. total bilirubin ≤ 1.5 times the upper limit of normal (ULN)\n    2. aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3.0 times the ULN\n13. The participant has adequate hematologic function without Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) injection or transfusion in the prior 7 days, as evidenced by:\n\n    1. an absolute neutrophil count (ANC) greater than or equal to 2000 \u002F μL\n    2. hemoglobin greater than or equal to 8 g\u002FdL\n    3. platelets greater than or equal to 100,000 \u002F μL\n14. For phase 1a, participant must be willing to undergo 2 core needle biopsies that are accessible via ultrasound and\u002For clinical biopsy.\n15. Adequate uptake of 86Y-NM600 (2x red bone marrow) on PET CT imaging.\n16. No grade 2 toxicities that are new compared to baseline and lack a possible alternative explanation (e.g., underlying disease or another known cause) were noted by Day 7 after the 86Y-NM600 infusion. Toxicities with at least a possibly related attribution to disease and\u002For another cause-even if also considered at least possibly related to 86Y-NM600-are permitted.\n17. No Grade ≥ 3 toxicities that are new compared to baseline were noted by day 7 after 86Y-NM600 infusion.\n\nExclusion Criteria:\n\n1. Other concurrent severe and\u002For uncontrolled concomitant medical or psychiatric conditions (e.g., active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol, per investigator discretion.\n2. The participant is taking strong inducers or inhibitors of CYP450 enzymes or drug transporters that cannot be held from at least 30 days prior to administration of 86Y-NM600 through the final 90Y-NM600 infusion without any expected adverse events. Examples include: clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, phenobarbital, phenytoin, rifampicin, and glucocorticoids.\n3. Chemotherapy, radiotherapy, or major surgery within 3 weeks prior to study enrollment (this will be greater than 5 weeks prior to 90Y-NM600 therapy).\n\n   a. For patients receiving prior radiation therapy, the dose to tumor, kidneys, liver, and bone marrow must be recorded, if available.\n4. The participant is pregnant, breastfeeding, or expecting to conceive or could impregnate someone within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.\n5. Any ongoing or active infection, including active tuberculosis, hepatitis B or C, or known infection with the human immunodeficiency virus (HIV) that is not well controlled (undetectable viral load by PCR) by anti-retroviral therapy.\n6. Concurrent treatment with any other systemic anti-cancer or investigational agents other than an anti-PD-1, anti-PD-L1, anti-CTLA-4, or anti-LAG-3 antibody. Subjects cannot be receiving concomitant chemotherapy, experimental therapy or any other therapy not otherwise outlined by the trial for the purposes of anti-cancer treatment.\n\n   b. Palliative external beam radiation therapy may be delivered to patients during this study if deemed necessary and safe by the treating physician.\n\n   c. Participants can be receiving dual immune checkpoint inhibition with an anti-CTLA-4 antibody or an anti-LAG-3 antibody in addition to an anti-PD-1 or anti-PD-L1 therapy.\n7. Patients with a history of or concurrent second primary malignancy within 2 years to study enrollment are excluded, with the exception of patients who have had definitive treatment of a primary skin basal cell, skin squamous cell carcinomas, or localized low or intermediate risk prostate cancer - these subjects are eligible 3 months after completion of definitive treatment for that prior cancer.\n8. Participants that have had total body or hemibody irradiation, or have had prior systemic radioisotope therapy (except for benign thyroid disease)\n9. Any condition requiring the use of immunosuppression, excluding rheumatologic conditions or endocrine conditions treated with stable doses of corticosteroids (equivalent to prednisone 10 mg daily)\n10. Ongoing hemodialysis or peritoneal dialysis\n11. Any known medical condition that predisposes the subject to uncontrolled bleeding such as hemophilia or clotting factor deficiencies\n12. Participants with known genetic conditions causing pre-disposition to RT toxicity (i.e.: Li-Fraumeni, ataxia telangiectasia mutated (ATM) deficiency, active scleroderma, active inflammatory bowel disease, active systemic lupus)\n13. Patients with an implanted defibrillator or with an implanted pacemaker and pacemaker dependency for rate or rhythm control\n14. Patients with repeated demonstration on two EKGs of a QTcF interval greater than 470 milliseconds or use of medications known to prolong the QT\u002FQTc interval\n15. Participants who cannot provide independent, legal, informed consent",{"count":54,"type":22},60,[25],"Participants with metastatic cancer who are taking anti-PD-1 or anti-PD-L1 therapy will be enrolled to assess the safety of and find the optimal dose for radioactive imaging agents and to explore whether these agents will make current drug therapies work better. Up to 60 participants will be enrolled and can expect to be on study for up to 9 months.",[30],"2026-08-17",{"date":34,"type":37},{"date":61,"type":22},"2026-11-01",{"date":63,"type":22},"2028-09",{"name":65,"class":66},"University of Wisconsin, Madison","OTHER",1,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":78,"conditions":79,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100509886","phase-1-fog-001-in-locally-advanced-or-metastatic-solid-tumors-100509886","NCT05919264","FOG-001 in Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ and marrow function.\n\nAdditional Inclusion Criteria for Dose Escalation Cohorts (Part 1a and Part 1g):\n\n* Diagnosis of treatment-refractory advanced\u002Fmetastatic solid tumor that is non-MSI-H or non-dMMR colorectal cancer (CRC) or any other solid tumor with documented WNT- pathway activating mutations (WPAMs).\n\nAdditional Inclusion Criteria for Dose Escalation Cohorts (Part 1b):\n\n* Diagnosis of treatment-refractory advanced\u002Fmetastatic non-MSI-H or non-dMMR CRC.\n* At least one lesion that is suitable for a core needle biopsy.\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):\n\n* Histologically, cytologically, or radiographically confirmed HCC with a documented WPAM (by local ctDNA or tumor NGS testing) in APC or CTNNB1\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d, Part 1h, and Part 2d):\n\n* Desmoid tumor (aggressive fibromatosis)\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.\n* One dose of mFOLFOX6 with or without bevacizumab in the unresectable or metastatic setting prior to enrollment is allowed.\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab\n\n* Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases.\n* MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1\u002FPD-L1\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine\u002FTipiracil + Bevacizumab\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.\n\nMonotherapy Dose Optimization (Part 1i): FAP\n\n* Diagnosis of phenotypic classical FAP with a documented APC mutation\n* Post-colectomy \\>6 months prior to first dose of study drug administration with measurable duodenal polyp burden\n\nAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2a):\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC\n\nAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2b):\n\n* Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence\n\nExclusion Criteria:\n\n* Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC. For participants with FAP, osteomas are allowed.\n* Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months and who are not receiving antiresorptive therapy.\n* Osteoporosis, which is defined as a T-score of ≤-2.5 at the lumbar spine (L1 - L4), left (or right) femoral neck or left (or right) total hip as determined by DXA scan.\n* Uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)\n* Unstable\u002Finadequate cardiac function.\n* Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases.\n* Pregnant, lactating, or planning to become pregnant.\n* Complete colectomy within 6 months of the first dose of study drug administration.",{"count":76,"type":22},619,[25,26],"The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors or in participants with familial adenomatous polyposis (FAP).",[80,81,82,83,30,84,85,86,87,88,89,90,91,92,93],"Cancer","Colorectal Cancer","Solid Tumor","Locally Advanced Solid Tumor","WNT Pathway","HCC","Desmoid","Microsatellite Stable Colorectal Cancer","Metastatic Castration-resistant Prostate Cancer","Familial Adenomatous Polyposis (FAP)","Endometrial Carcinoma","Prostate Cancer","Microsatellite Instability-High Colorectal Cancer","Adamantinomatous Craniopharyngioma",[80,82,83,30,95,96,97,86,98,99,100,101,102],"WNT Pathway Activating Mutation (WPAM)","Colorectal Cancer (CRC)","Microsatellite Stable (MSS)","Hepatocellular Carcinoma (HCC)","Adenomatous Polyposis Coli (APC)","β-catenin","Beta-catenin","CTNNB1","2026-08-13",{"date":58,"type":37},{"date":106,"type":37},"2023-05-23",{"date":108,"type":22},"2027-08-31",{"name":110,"class":44},"Parabilis Medicines, Inc.",33,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":120,"type":22},250,[25],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[29,124,30,125,126,127,128,129,130,131,132,133,81,134,135,136,137,138,139,140,141,142],"Advanced Cancer","Squamous Cell Carcinoma of Head and Neck","Non Small Cell Lung Cancer","Small-cell Lung Cancer","Bladder Cancer","Sarcoma","Endometrial Cancer","Melanoma","Castration Resistant Prostatic Cancer","Cervical Cancer","Gastric Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Clear Cell Renal Cell Carcinoma","Hepatocellular Carcinoma","Platinum-resistant Ovarian Cancer","Breast Cancer","Ovarian Cancer","Esophageal Squamous Cell Cancer (SCC)","2026-08-10",{"date":145,"type":37},"2026-08-11",{"date":147,"type":37},"2024-03-06",{"date":149,"type":22},"2028-10",{"name":151,"class":44},"MacroGenics",12,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":180,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},"100505262","phase-1-a-study-of-mq710-with-and-without-pembrolizumab-in-people-with-solid-tumor-cancer-100505262","NCT05859074","A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer","A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors","Inclusion Criteria:\n\n* Age 18 or over\n* Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two lines of prior therapy in the advanced setting unless there are fewer than two FDA approved lines of therapy for the particular disease, or for which no standard treatment is available\n* At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of lesions, ≥0.5 cm for any single lesion and cumulative lesion dimensions. One lesion must meet criteria for RECIST measurable disease if in Part 2. Note: One lesion will be biopsied (if possible)\n* Mandatory initial screening biopsy\n\n  a. For patients undergoing surgical excision\u002Fresection: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to biopsy and surgical procedure iii. Patient able to undergo surgical procedure and appropriate anesthesia b. For patients not undergoing surgical excision\u002Fresection to obtain mandatory screening biopsy: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to initial tumor biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients with no curative treatment options available including surgery and\u002For definitive radiation or patients in which these modalities are associated with significant morbidity\n* Patients with advanced disease who have received and progressed on standard therapy or have disease for which there is no standard therapy or have contraindications to standard therapy\n\nPart 1a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. Any malignancy with superficial cutaneous or subcutaneous lesions or palpable lymph nodes may be eligible based on the discretion of the investigator.\n\n* Part 2a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. BCC will also be included, given that pembrolizumab has not been approved for this condition, although cemiplimab is approved.\n* Parts 1b and 2b: Patients must have cSCC, Merkel cell carcinoma, melanoma, or head and neck squamous cell carcinoma. These patients should be refractory to anti-PD-1 therapy, with the exception of patients with HNSCC with PD-L1 expression \\\u003C1.\n* Parts 1a, 2a and 2b: Patients with BRAF-mutated melanoma should have received BRAF-targeted therapy.\n* Predicted life expectancy of 3 months or more (in both Part 1 and Part 2)\n* Participant or their legally authorized representative (LAR able to provide written informed consent to participate\n* Ability to comply with study procedures in the Investigator's opinion\n* Adequate renal function as defined by Cr \\\u003C2 mg\u002FdL\n* Adequate hepatic function\n\n  1. Serum bilirubin ≤1.5 x ULN\n  2. AST and ALT ≤2.5 ULN (no liver mets)\n  3. AST and ALT ≤5.0 ULN (for patients with liver mets)\n* Adequate bone marrow and hematologic function\n\n  1. Coagulation function adequate (PT and aPTT within x1.5 ULN)\n  2. Platelets ≥ 75,000\u002Fmm\\^2\n  3. ANC ≥ 1000\u002FuL\n* Females of child-bearing potential must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days after the last dose of MQ710\n* Part 2 only: at least one measurable site of disease according to RECIST criteria\n* Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical\u002Fradiotherapy, targeted therapy, or major surgery (but not anti-PD1\u002F- L1 therapies) was discontinued for more than 4 weeks prior to enrollment\n* Patients who have failed prior anti-PD1\u002F-PDL1 may be included. Washout of anti-PD1\u002F-PDL1 at least 3 weeks prior to initiation of therapy in Part 1a and 2a. No washout period is required for Part 1b and 2b.\n\nExclusion Criteria:\n\n* Splenectomy\n* Active infections requiring antibiotics, physician monitoring or recurrent fevers (\\>38.0 ℃) associated with a clinical diagnosis of active infection\n* Acute or chronic active viral disease or positive test for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) with CD4 count \\\u003C100mg\u002Fm3, or received treatment with antivirals or nucleoside analogs such as those used in the treatment of hepatitis B (e.g. lamivudine, adefovir, tenofovir, telbivudine, entecavir), ribavirin, cidofovir, diaminopurine analogs, methyladenosine analogs, or interferon alpha within 4 weeks of initiation of study treatment .a. Patients with HIV are allowed on study if CD4 count is \\>100 cells\u002Fmm3.\n* Incomplete recovery from surgery, incomplete healing of an incision site\n* Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding\u002Fhaemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia\n* History of myocardial infarction, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classsification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia,or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment\n* Uncontrolled infection within 6 months prior to study entry.\n* History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment\n* Treatment with PD-1\u002Fprogrammed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 3 weeks before the first dose of study treatment\n* Prior chemotherapy, radiotherapy, biological cancer therapy (not including anti-PD1\u002F-L1 immunotherapies), targeted therapy, investigational drug, or major surgery 28 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment with the exception of grade 2 or better for alopecia and neuropathy.\n* Has known active CNS metastases and\u002For carcinomatous meningitis\n* Received live vaccine within 28 days prior to enrollment\n* Patient is pregnant or breast-feeding, or expecting to conceive or father children within the duration of the trial\n* Patients with tumor that directly contacts, encases or penetrates a major blood vessel, pericardium, gastrointestinal tract, or other hollow organs that may lead to perforation due to tumor necrosis\n* Patients at risk of airway compromise in the event of post-injection tumor swelling\u002Finflammation based on investigator judgement\n* History or evidence of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)\n* History of chronic liver disease or evidence of hepatic cirrhosis\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, active interstitial lung disease (ILD) requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% on room air\n* History of re-irradiation to a field which includes the carotid arteries\n* History of leukemia: ALL and CLL (patients with a history of aggressive lymphomas in remission or patients with a history of allogeneic stem cell transplants are eligible if no longer on immunosuppressive therapy and without evidence of GvHD)\n* Current use of steroids such as prednisone 10 mg\u002Fdaily or greater (or its equivalent) or immunosupressants within 2 weeks of initiation of study treatment\n* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results\n* Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent\n* Known allergy to MQ710 transgene products or formulation.\n* Patient requires anticoagulation therapy, such as warfarin.",{"count":161,"type":22},56,[25],"Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.",[165,166,167,168,169,131,170,171,172,173,174,175,176,177,178,124,30,179,82],"Cutaneous Squamous Cell Carcinoma","SCC - Squamous Cell Carcinoma","Basal Cell Carcinoma","BCC","BCC - Basal Cell Carcinoma","Merkel Cell Carcinoma","Sebaceous Carcinoma","Extramammary Paget Disease","Kaposi Sarcoma","Head and Neck Squamous Cell Carcinoma","HNSCC","Adnexal Carcinoma","Angiosarcoma","Cutaneous Neoplasm","Refractory Cancer",[165,166,167,168,131,170,171,172,173,174,175,176,177,178,124,30,179,181,182,183,82],"MQ710","Memorial Sloan Kettering Cancer Center","22-278",{"date":185,"type":37},"2026-08-12",{"date":187,"type":37},"2023-05-04",{"date":189,"type":22},"2028-05-04",{"name":182,"class":66},7,{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":18,"minAge":199,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":228,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100407463","the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":201,"type":22},300,[25,26],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[29,205,30,206,207,141,130,91,81,140,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227],"Advanced Malignant Neoplasm","Metastatic Solid Tumor","Lung Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt","2026-08-07",{"date":143,"type":37},{"date":260,"type":37},"2020-10-29",{"date":262,"type":22},"2027-12-31",{"name":264,"class":44},"PMV Pharmaceuticals, Inc",77,{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100459823","phase-1-study-of-au-007-a-monoclonal-antibody-that-binds-to-il-2-and-inhibits-il-2r-binding-in-patients-with-unresectable-locally-advanced-or-metastatic-cancer-100459823","NCT05267626","Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer","A Phase 1\u002F2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer","Selected Inclusion Criteria:\n\n* Patients must have measurable disease as per RECIST v1.1 criteria and documented by CT and\u002For MRI\n* Part 2 includes but is not limited to:\n* Cutaneous melanoma that is either locally unresectable or metastatic:\n\n  * BRAF wild type: progressed after receiving PD-1 containing therapy with or without an anti-CTLA-4\n  * BRAF mutation: patients who refused BRAF+MEK inhibitor\n  * Must have objective progression after receiving at least two cycles of prior doublet therapy (anti-PD-1\u002Fanti-CTLA-4 or anti-PD-1\u002Fanti-LAG-3)\n  * Radiographic progression ≥ 4 weeks prior to the first dose of study drug to rule out late response to most recent therapy. The requirement for documented radiologic progression may be waived after review by Medical Monitor (e.g., in the case of progression beyond 12 weeks after starting a doublet)\n  * LDH ≤ 2.5 x ULN\n* NSCLC: Unresectable locally advanced or metastatic PD-L1-positive (tumor proportion score \\[TPS\\] ≥ 1%) NSCLC not harboring an activating EGFR mutation or ALK rearrangement and has progressed during or following treatment with an anti-PDx with or without platinum-based chemotherapy\n* Part 3: NSCLC as described above\n* Part 4: cutaneous melanoma\n\n  * Unresectable locally advanced or metastatic cutaneous melanoma that has progressed during or following treatment with an anti-PDx (unless ineligible for anti-PDx therapy)\n  * Patients with BRAF mutations must either be ineligible for or have refused a BRAF+MEK inhibitor\n  * Must have objective progression after receiving at least two cycles of prior doublet therapy (anti-PD-1\u002Fanti-CTLA-4 or anti-PD-1\u002Fanti-LAG-3).\n  * Radiographic progression ≥ 4 weeks prior to the first dose of study drug to rule out late response to most recent therapy. The requirement for documented radiologic progression may be waived after review by Medical Monitor (e.g., in the case of progression beyond 12 weeks after starting a doublet)\n  * LDH ≤ 2.5 x ULN\n* Female patients of childbearing potential must have a negative serum or urine pregnancy test performed within 72 hours prior to the initiation of study drug administration. Female patients of childbearing potential must be willing to use two forms of contraception throughout the study, starting with Screening through 60 days after the last dose of study drug (or 5 months after the last dose of study drug for patients receiving nivolumab). Abstinence is acceptable if this is the established and the preferred contraception method for the patient\n* Male patients with partners of childbearing potential must use barrier contraception from the time of consent through 60 days after discontinuation of study drug and must not donate sperm during this period. In addition, male patients should have their partners use contraception (as documented for female patients) for the same period of time\n* Patients who have previously received an immune checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have checkpoint inhibitor immune-related toxicity resolved to either Grade ≤ 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous checkpoint inhibitor-related hypothyroidism are eligible for the study regardless of grade resolution if well controlled on thyroid hormone replacement therapy\n* Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:\n* No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids ≥ 10 mg prednisone\u002Fday or equivalent)\n* No concurrent leptomeningeal disease or cord compression\n\nExclusion Criteria:\n\n* Patients with a history of known autoimmune disease with exceptions of\n\n  * Vitiligo\n  * Psoriasis, atopic dermatitis, or other autoimmune skin condition not requiring systemic treatment\n  * History of Graves' disease in patients now euthyroid for \\> 4 weeks\n  * Hypothyroidism managed by thyroid hormone replacement\n  * Alopecia\n  * Arthritis managed without systemic therapy beyond oral nonsteroidal anti- inflammatory drugs\n* Major surgery or traumatic injury within 3 weeks before first dose of AU-007\n* Unhealed wounds from surgery or injury\n* Treatment with \\> 10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within the 7 days prior to the initiation of study drug. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed\n* Prior anti-cancer therapy before the planned start of AU-007 as follows:\n\n  * Not recovered to baseline from toxicity of prior systemic cancer therapy(ies).\n  * Not recovered from toxicity of radiotherapy.\n  * Concurrent use of hormones either to maintain castrate levels of testosterone in patients with castration-sensitive prostate cancer or for non-cancer-related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable. Bisphosphonates are permitted.\n* Patients who have experienced serious adverse events during prior IL-2 therapy (including but not limited to bowel perforation, gastrointestinal bleeding, arrythmias, myocardial infarction, repetitive seizures).\n* Inflammatory process that has not resolved for ≥ 4 weeks from the date of first study dose. Patients with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of duration\n* Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required therapy, with the exception of indolent lymphomas",{"count":274,"type":22},159,[25,26],"This is a first in human, open-label, multi-center Phase 1 \u002F 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007, also known as imneskibart, in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w). Once the recommended phase 2 dose (RP2D) of AU-007 plus aldesleukin was determined, (AU-007 Q2w plus a single loading dose of aldesleukin), AU-007 plus aldesleukin is also being administered with avelumab or nivolumab.",[29,30,278,222],"Cutaneous Melanoma",[280,281,131,282,283,134,284,285,286,215,128,287,288,289,290,291,292,293,294,295,296],"IL-2 CD25","IL-2Ra","Head and neck squamous cell carcinoma","Urothelial cancer","Gastro-esophageal cancer","CD25","IL-2","Merkel Cell Cancer","Proleukin","Immune Therapy","Immunotherapy","Cutaneous Squamous Cell Cancer","Cytokine","Anti-PD-L1","Non-small cell lung cancer","Clear cell renal cell cancer","imneskibart","2026-07-29",{"date":299,"type":37},"2026-07-30",{"date":301,"type":37},"2022-04-04",{"date":303,"type":22},"2027-02-28",{"name":305,"class":44},"Aulos Bioscience, Inc.",18,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":317,"phases":4,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":67},"100458093","augsburg-longitudinal-plasma-study-for-the-evaluation-of-liquid-biopsy-as-diagnostic-tool-100458093","NCT05245136","Augsburg Longitudinal Plasma Study for the Evaluation of Liquid Biopsy as Diagnostic Tool.","Augsburg Longitudinal Plasma Study (ALPS) to Study Liquid Biopsy (LBx) as a Tool for Diagnostic Support, Assessment of Disease Progression, and Identification of Mutations During Disease Course in Patients With Solid Neoplasms Receiving Palliative Treatment","ALPS","Inclusion Criteria:\n\n* Written informed consent\n* Age ≥ 18 years\n* Histopathologically confirmed metastatic or locally advanced cancer\n* No curative treatment options, except for germ cell tumors\n* Written Agreement to be followed up at Augsburg University Medical Center\n* Signed written informed consent for the Biobank Augsburg (Biobank-A)\n* Willing to undergo treatment according to standard of care\n* Availability or anticipated availability of tumor tissue at time point of inclusion\n* Anticipated life expectancy of at least 3 months at time point of trial inclusion\n\nExclusion Criteria:\n\n* Psychological condition that would preclude informed consent\n* Additional tumor treatment between acquisition of tumor tissue and trial inclusion",{"count":316,"type":22},3000,"OBSERVATIONAL","A prospective observational trial of patients with metastatic cancer of various entities which aims at both clarifying the significance of liquid biopsy and establishing a foundation for translational research.",[320,30,82],"Characteristics Disease",{"date":299,"type":37},{"date":323,"type":37},"2021-03-29",{"date":325,"type":22},"2030-03",{"name":327,"class":66},"University Hospital Augsburg",{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":345,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":354},"100412938","phase-1-a-study-of-art0380-for-the-treatment-of-advanced-or-metastatic-solid-tumors-100412938","NCT04657068","A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors","A Phase I\u002FIIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors","General Inclusion Criteria:\n\n* Signed informed consent\n* Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy to CTCAE Grade ≤1. Palliative radiotherapy must have completed 1 week prior to start of study treatment.\n* If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated\n* At least 1 radiologically evaluable lesion (measurable and\u002For non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 or Prostate Cancer Working Group-3 Guidelines (PCWG-3)\n* Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and granulocyte colony-stimulating factor\n* Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis.\n* Female patients of childbearing potential and male patients with female partners of childbearing potential are required to use highly effective contraception plus one barrier method during their participation in the study and for 7 months and 5 months respectively following the last dose. For male and female patients given gemcitabine or irinotecan, highly effective contraception plus one barrier method must be used from study entry until 6 months after the last dose of study treatment. Male patients are required to refrain from donating sperm and female patients are required to refrain from donating eggs, during their participation in the study and for 6 months following last dose.\n* Estimated life expectancy of ≥12 weeks\n* Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n* Performance status of 0-1 on the ECOG Scale\n\nAdditional inclusion criteria for participants in dose escalation (Part A1):\n\n* Advanced or metastatic cancer which is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study\n* Performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale\n\nAdditional inclusion criteria for participants in dose escalation (Part A2):\n\n•Advanced or metastatic cancer for which gemcitabine is an appropriate treatment. Prior treatment with gemcitabine is permitted.\n\nAdditional inclusion criteria for participants in dose escalation (Part A3):\n\n* Advanced or metastatic cancer for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted.\n* For food effect cohort only: Patients must be able to eat a high-fat meal within a 30 minute period, as provided by the study site.\n\nAdditional inclusion criteria for participants in dose expansion (Part B1):\n\n* Patients with advanced or metastatic solid tumors with alterations to the ATM gene likely to predict for loss of ATM protein\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1\n* For France only ART0380 Monotherapy; Patient that is not eligible for curative treatment, for whom all standard of care therapies have failed and no therapies known to provide clinical benefit are available.\n* Combination arms; Patients for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted.\n* For Spain only ART0380 Combination therapy, Patient that is not eligible for curative treatment, for whom standard of care therapies have failed.\n\nAdditional inclusion criteria for participants in dose expansion (Part B2):\n\n* Patients with a known germline BRCA mutation, or a cancer with a known somatic BRCA mutation, or which is known to be HRD positive, and for which there is an approved PARP inhibitor should have received such treatment before participating in the study, unless contra-indicated.\n* Females with histologically-confirmed diagnosis of high grade serous carcinoma of the ovary, fallopian tube or primary peritoneum that is not amenable to curative therapy\n* Platinum-resistant disease. Patients must not have had primary platinum-refractory disease (disease that progressed during first-line platinum-based therapy).\n* No more than one prior regimen in the platinum-resistant setting. Hormonal therapies and antiangiogenic therapies (as single agents) and PARP inhibitors used as maintenance therapy are not considered as separate lines of therapy. Patients should have previously received bevacizumab and chemotherapy unless contra-indicated.\n* Have not received prior treatment with gemcitabine unless administered in combination with a platinum with no disease progression within 12 months after completion of that regimen\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1\n\nInclusion criteria specific to Part B3\n\n* Persistent or recurrent endometrial cancer with biological selection.:\n* Patients should have received taxane\u002Fplatinum chemotherapy, unless contraindicated.\n* Measurable disease.\n\nInclusion criteria specific to Part B4\n\n* Advanced or metastatic solid cancers of any histology with biological selection\n* If a PD-1\u002FPDL-1 inhibitor (eg, pembrolizumab) is approved and available for the patient's cancer, the patient should have received such treatment before participating in this study.\n* Radiologically evaluable disease\n* Performance status of 0-1 on the ECOG scale\n\nInclusion criteria specific to Part B5\n\n* Metastatic CRC with alterations to the ATM gene\n* Participants should have previously received appropriate prior lines of therapy in this setting.\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1.\n* Patients have received a maximum of 2 prior chemotherapy regimens for the treatment of CRC.\n* Serum albumin ≥3g\u002FdL within 7 days prior to first dose.\n* ECOG Performance Status must be stable for at least 2 weeks prior to enrollment.\n* Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease\n\nInclusion criteria specific to Part B6:\n\n* Metastatic or locally advanced PDAC or acinar cell carcinoma with alterations to the ATM gene\n* Participants must have received at least 1 prior chemotherapy regimen for the treatment of the advanced disease OR have received neoadjuvant\u002Fadjuvant therapy with recurring occurring \\\u003C6 months following completion of this treatment.\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1. Previously irradiated lesions may not be considered target lesions.\n* Serum albumin ≥3g\u002FdL within 7 days prior to first dose.\n* ECOG Performance Status must be stable for at least 2 weeks prior to enrollment.\n* Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease.\n\nGeneral Exclusion Criteria:\n\n* Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within 7 months after the last administration of study treatment\n* Men who plan to father a child while in the study or within5 months after the last administration of study treatment\n* Serious concomitant systemic disorder that would compromise the participants ability to adhere to the protocol including: one or more opportunistic HIV\u002FAIDs-related infections within the past 12 months, a known hepatitis B virus, or known hepatitis C virus; documented active or chronic tuberculosis infection; malignancy prior to the one currently being treated that is not in remission\n* Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).\n* Moderate or severe cardiovascular disease\n* Valvulopathy that is severe, moderate, or deemed clinically significant\n* Documented major electrocardiogram (ECG) abnormalities which are clinically significant\n* Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment\n* Received a live vaccine within 30 days before the first dose of study treatment\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate\n* Recent major surgery within 4 weeks prior to entry into the study or minor surgery within 1 week of entry into the study\n* Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks before the first dose of study treatment.\n* A significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment\n* Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study\n\nAdditional exclusion criteria for participants in dose escalation (Part A3, B1, B5, and B6 in combination with irinotecan):\n\n* Patients who have symptoms or signs of clinically unacceptable deterioration of the primary disease at the time of screening.\n* Patients who are known to be homozygous for both UGT1A1 \\*6 and \\*28 (UGT1A1 7\u002F7 genotype), or simultaneously heterozygous for both UGT1A1 \\*6 and \\*28.\n* Patients receiving strong inhibitors of UGT1A1 within 2 weeks before the first dose of study treatment\n* Part A3 Fed-fasted cohort only: Patients receiving acid reducing agents within 1 week before the first dose of study treatment will be excluded\n* Part B6: Neuroendocrine (carcinoid, islet cell) or adenosquamous carcinoma pancreatic cancer\n* Parts B5 and B6: Initiation of opioids in the previous 2 weeks.\n* Parts B5 and B6: Weight loss \\>10% in the previous 8 weeks.\n* Parts B5 and B6: Active intestinal obstruction, ileus, or significant malabsorption.",{"count":336,"type":22},542,[25,26],"This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to:\n\n* Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan\n* Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan\n* Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan",[124,30,141,340,341,130,342,343,344],"Primary Peritoneal Cancer","Fallopian Tube Cancer","Metastatic Colorectal Cancer","Pancreatic Ductal Adenocarcinoma","Acinar Cell Carcinoma",[346],"Loss of Ataxia Telangiectasia Mutated (ATM) protein",{"date":299,"type":37},{"date":349,"type":37},"2021-01-27",{"date":351,"type":22},"2028-06",{"name":353,"class":44},"Artios Pharma Ltd",82,{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":67},"100596296","phase-2-zanzalintinib-for-metastatic-clear-cell-renal-cell-carcinoma-with-bone-metastases-100596296","NCT07043608","Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases","A Phase II Study of Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases in Patients Previously Treated With Immune Checkpoint Inhibitors","ZAMBONI","Inclusion Criteria:\n\n1. Participants must have unresectable advanced or metastatic RCC with a predominant clear cell histologic component .\n2. At least three bone metastases are present and detectable on bone scan, and at least one bone metastasis is NOT planned to be treated with radiation therapy.\n3. Previously treated with 1-3 prior lines of therapy in at least one of the following settings:\n\n   1. Metastatic setting; must have received combination therapy containing either programmed cell death protein 1 (PD-1) inhibitor\u002Fcytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor or PD-1 inhibitor\u002Fvascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitors (TKI).\n   2. Adjuvant setting; must have received pembrolizumab and have had documented progression of disease within 1 year of the first dose of pembrolizumab .\n4. Age ≥18 years.\n5. Has seen a dentist within 90 days prior to enrollment and been cleared to receive bone-strengthening agents.\n6. Availability of a representative formalin fixed, paraffin embedded tumor specimen or fresh frozen tissue specimen that enables the definitive diagnosis of RCC, accompanied by an associated pathology report. If stored specimens are not available, an optional biopsy may be performed and specimens can be collected by surgical resection or biopsy of the primary tumor or biopsy or resection of a metastatic lesion.\n7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n8. Demonstrates adequate organ function as defined below within 14 days prior to first study treatment:\n\n   1. Absolute neutrophil count (ANC) \\>=1,500\u002F μL (without granulocyte colony stimulating factor support within 2 weeks prior to Cycle 1, Day 1).\n   2. Platelets ≥100,000\u002F μL (without transfusion within 2 weeks prior to Cycle 1, Day 1).\n   3. White Blood Cell count (WBC) counts ≥ 2500\u002FμL.\n   4. Lymphocyte count ≥ 500\u002FμL.\n   5. Hemoglobin ≥9.0 g\u002FdL.\n\n      Participants may be transfused or receive erythropoietic treatment to meet this criterion:\n   6. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN). Participants with known Gilbert disease who have serum bilirubin level \\\u003C= 3 x ULN may be enrolled.\n   7. Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) ≤2.5 X institutional upper limit of normal.\n   8. Alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase (SGPT) ≤2.5 X institutional upper limit of normal.\n   9. Alkaline phosphatase ≤2.5 X institutional upper limit of normal. For participants with documented liver metastases: AST and\u002For ALT ≤ 5 x ULN. For participants with documented liver or bone metastases: alkaline phosphatase ≤ 5 x ULN.\n   10. Creatinine ≤ 1.5 x within institutional upper limit of normal OR creatinine clearance ≥ 40 mL\u002Fmin by institutional standard AND urine protein-creatinine ratio (UPCR) 1mg\u002Fmg.\n   11. International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. This applies only to participants who are not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose.\n   12. Serum ionized calcium above lower limit of normal and ≤ 1.5 x ULN.\n9. If any Grade ≥1 toxicities occurred in relation to prior treatment, patients must have recovered to baseline or ≤ Grade 1 unless adverse events are clinically insignificant or stable on supportive medication if needed.\n10. Ability to understand and the willingness to sign a written informed consent document.\n11. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n12. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n13. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n14. Sexually active fertile subjects and their partners must agree to use highly effective method of contraception (defined in Appendix 4) during the course of the study and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n\n    a. Through 186 days after the last dose of zanzalintinib for women of childbearing potential (WOCBP) or through 96 days after the last dose of zanzalintinib for men.\n15. Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating hormone (FSH) level \\> 40 milli-international units per millilitre (mIU\u002FmL) to confirm menopause). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff. Exception: women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and\u002For uterus).\n\nExclusion Criteria:\n\n1. Prior treatment with zanzalintinib for RCC.\n2. Receipt of any small molecule kinase inhibitor (including investigational) or vascular endothelial growth factor (VEGF)-targeted therapy within 2 weeks before the first dose of study treatment.\n3. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.\n4. Participants requiring whole brain radiotherapy (WBRT).\n5. Incomplete healing from prior radiotherapy as determined by the treating radiation oncologist or treating investigator.\n6. Participation in an experimental drug study within 28 days of study enrollment.\n7. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.\n8. Pregnant and lactating women are excluded from this study because zanzalintinib is an investigational product with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with zanzalintinib, breastfeeding should be discontinued if the mother is treated with zanzalintinib.\n9. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Cycle 1, Day 1.\n10. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation); Clinically significant hematuria, hematemesis, or hemoptysis of \\>0.5 tsp (2.5ml) of red blood or other history of significant bleeding within 12 weeks before first dose of study treatment.\n11. Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.\n12. Evidence of abdominal free air not explained by paracentesis or recent surgical procedure.\n13. Concomitant anticoagulation with coumarin agents, direct thrombin inhibitors, factor Xa inhibitor betrixaban, or platelet inhibitors. Other anticoagulants are allowed.\n\n    1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n    2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\n    i. Participants who have known brain metastases and who require therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban are not eligible for this study.\n\n    ii. Participants with known brain metastases and who are taking prophylactic low-dose aspirin for cardioprotection or low-dose (prophylactic-dose) low molecular weight heparin are eligible.\n\n    Note: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.\n14. Previously identified allergy or hypersensitivity to components of the treatment.\n15. Malignancy that requires anti-cancer directed therapy within the last 3 years. Exceptions include those cancers that are considered cured by local therapy (e.g. Basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of breast, bladder, or cervix) or other cancers that have low malignant potential and do not require systemic therapy (e.g. Gleason grade \\\u003C6 prostate adenocarcinoma).\n16. Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.\n17. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n18. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.\n19. Any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n20. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n    1. Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes).\n    2. Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n    3. Stroke (including transient ischemic attack (TIA)), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before first dose of study treatment.\n    4. Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.\n\n       Note: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\n       Note: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n    5. Prior history of myocarditis.\n    6. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n    i. Tumors invading the GI-tract from external viscera. ii. Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.\n\n    iii. Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic.\n\n    iv. Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n\n    v. Known gastric or esophageal varices. vi. Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks.\n21. Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n22. Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n23. Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Note: Subjects with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior V. cava) may be eligible following Principal Investigator approval.\n24. Other clinically significant disorders that would preclude safe study participation.\n\n    1. Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.\n    2. Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness except for subjects meeting all of the following criteria: (1) on stable anti-retroviral therapy; (2) Cluster of differentiation 4 positive (CD4+) T cell count ≥ 200\u002FµL; and (3) an undetectable viral load. Note: HIV testing will be performed at screening if and as required by local regulation. Note: To be eligible, participants taking Cytochrome P450, family (CYP) inhibitors (e.g., zidovudine, ritonavir, cobicistat, didanosine) or Cytochrome P450, family 3 (CYP3) inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose. Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.\n    3. Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n\n    i. Complete healing of intra-abdominal abscess must be confirmed before the first dose of study treatment d. Malabsorption syndrome. e. Pharmacologically uncompensated, symptomatic hypothyroidism. f. Moderate to severe hepatic impairment (Child-Pugh B or C). g. Requirement for hemodialysis or peritoneal dialysis. h. History of solid organ or allogeneic stem cell transplant.\n25. Major surgery (as defined in Section 6.6.2.3; e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (i.e. nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (e.g., simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment.\n\n    Note: Fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n26. Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.\n\n    Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n27. History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.\n28. Patients who are ineligible for CT contrast AND who are unable to undergo MRI for any reason.\n29. Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.\n30. Other conditions, which in the opinion of the Investigator, would compromise the safety of the participant or the participant's ability to complete the study.",{"count":364,"type":22},20,[26],"This is a single-institution, phase 2 trial of zanzalintinib plus investigator-choice bone-strengthening agent in patients with metastatic renal cell carcinoma (RCC) with bone metastases whose disease has advanced on 1-3 prior lines of therapy, including at least one immune oncology-based (IO) therapy in the adjuvant or first-line metastatic setting.",[368,369,370,371,372,137,373,30,374,375],"Clear Cell Renal Cell Cancer (ccRCC)","Clear Cell Renal Carcinoma","Clear Cell Renal Cell Carcinoma Metastatic","Clear Cell Renal Cancer","Bone Metastases of a Malignant Tumor","Bone, Metastatic Cancer","Metastatic Renal Cell Carcinoma","Metastases to Bone","2026-07-24",{"date":378,"type":37},"2026-07-27",{"date":380,"type":37},"2026-06-10",{"date":382,"type":22},"2030-04-30",{"name":384,"class":66},"Kelly Fitzgerald, MD",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":18,"minAge":199,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":23,"phases":393,"briefSummary":394,"conditions":395,"keywords":396,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":405,"locationsCount":407},"100575356","phase-1-slv-154-treatment-of-advanced-cancers-100575356","NCT06771219","SLV-154 Treatment of Advanced Cancers","A Phase 1 Dose-Escalation\u002FExpansion Study of SLV-154 in Subjects With Advanced Cancers","Inclusion Criteria:\n\n1. Men or women (as appropriate for cancer type) of age ≥12 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n3. Histologically or cytologically confirmed diagnosis of advanced cancer as documented in medical records.\n4. Presence of metastatic or recurrent locally advanced cancer.\n5. Presence of radiographically measurable disease.\n6. Prior receipt of one or more commercially available therapies that are indicated within product labelling or recommended under current guidelines as appropriate treatment for the subject's cancer (unless evolving data support application of SLV-154 in previously untreated subjects with high unmet medical need and inadequate and\u002For poorly tolerated treatment options).\n7. Availability of tumor tissue from a fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival tumor sample from a previous biopsy.\n8. Availability of computed tomography (CT) or magnetic resonance imaging (MRI) of chest, abdomen, and pelvis, and\u002For fluorodeoxyglucose (FDG) positron emission tomography (PET)\u002FCT (if appropriate for tumor type) (with PET from base of the skull to mid-thigh, if performed) within 35 days before study drug administration.\n9. Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study drug administration.\n10. Adequate hematological profile.\n11. Adequate coagulation profile.\n12. Adequate hepatic profile.\n13. Adequate renal function.\n14. Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.\n15. For female subjects of childbearing potential, a negative serum pregnancy test.\n16. For female subjects of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.\n17. For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol-recommended method of contraception from the start of study therapy until ≥6 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy.\n18. Willingness and ability of the subject to comply with scheduled visits, the drug administration plan, protocol-specified laboratory tests, other study procedures (including required tumor biopsy\u002Faspirations and\u002For radiographic studies), and study restrictions.\n19. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\n1. Unstable malignancy involving the central nervous system.\n2. Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.\n3. Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.\n4. Significant cardiovascular event or comorbidity.\n5. Significant screening ECG abnormalities.\n6. Pregnancy or breastfeeding.\n7. Major surgery within 3 weeks before the start of study therapy.\n8. Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.\n9. Concurrent participation in another therapeutic or imaging clinical trial.\n10. Other conditions likely to interfere with a subject's ability to participate in the study.",{"count":120,"type":22},[25],"This is a Phase 1 study comprising a Phase 1a dose-escalation portion and a Phase 1b expansion portion evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with advanced solid tumors.",[124,29,30],[397,398,399],"metastatic solid tumors","metastatic cancer","solid tumor","2026-07-22",{"date":376,"type":37},{"date":403,"type":37},"2025-05-14",{"date":41,"type":22},{"name":406,"class":44},"Solve Therapeutics",10,{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":67},"100438472","phase-2-stereotactic-ablative-radiotherapy-for-oligo-progressive-disease-refractory-to-systemic-therapy-in-metastatic-cancer-100438472","NCT04989725","Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer","Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer: A Phase II Randomized Trial","SUPPRESS","Inclusion Criteria:\n\n* Age ≥18 years\n* Metastatic cancer (any histology), with pathological or radiological proof of metastasis\n* Ability to provide written informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Progressive disease while on systemic treatment (any line), defined as per RECIST criteria 1.1 on CT metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on CT.\n* Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.\n* All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)\n* Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.\n* Presence of spinal cord compression\n* Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel",{"count":417,"type":22},46,[26],"A registry-based randomized phase II trial. A total of 46 patients with metastatic cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.",[30,421],"Oligoprogressive",[398,423],"oligoprogression","2026-07-21",{"date":400,"type":37},{"date":427,"type":37},"2021-10-01",{"date":429,"type":22},"2029-03-01",{"name":431,"class":66},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":23,"phases":440,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":67},"100569395","a-study-of-the-apricitycare-program-for-early-detection-and-management-of-treatment-related-adverse-events-in-patients-with-cancer-100569395","NCT06693687","A Study of the ApricityCare Program for Early Detection and Management of Treatment-Related Adverse Events in Patients With Cancer","Inclusion Criteria:\n\n* Age 18 years of age or older\n* Confirmed diagnosis of cancer\n\n  * Part 1 (Run-in Phase): Only patients with prostate, kidney, and\u002For bladder cancer will be enrolled with either localized or metastatic disease.\n  * Part 2 (Expansion Phase): Metastatic patients will be enrolled. Note, evaluable metastatic patients from Ppart 1 will be counted in Cohort A as described in section 8.4.\n* Planned to receive systemic anti-cancer therapy\n* Ability to understand and the willingness to sign a written informed consent document\n* Ability to speak, read, and understand one of the following languages: English, Spanish, Mandarin and Cantonese Chinese\n* Ownership of a smartphone and willingness to use it as outlined by the protocol and described in the ICF\n\nExclusion Criteria:\n\n\\- Have any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study (pregnancy is not exclusionary and pregnant women will be permitted to enroll in the study).",{"count":439,"type":22},425,[441],"NA","To evaluate the rate of therapy discontinuation due to toxicity (side effects) among participants with cancer using ApricityCare.\n\nInvestigators want to learn if identification of early clinical signs of irAEs with timely treatment can prevent severity progression and reduce treatment discontinuation.",[30],"2026-07-14",{"date":446,"type":37},"2026-07-16",{"date":448,"type":37},"2024-12-18",{"date":450,"type":22},"2027-11-01",{"name":452,"class":66},"M.D. Anderson Cancer Center",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":463,"conditions":464,"keywords":466,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":478,"locationsCount":67},"100584961","progress-precision-oncology-using-genomic-reflexive-evaluations-for-study-selection-and-survival-100584961","NCT06896162","PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival","PROGRESS","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* ECOG or Karnofsky Performance Status of 0-2.\n* Documented Stage IV solid tumor malignancy: NSCLC, CRC, Breast or Bladder Cancer\n* The treating provider deems Next Generation Sequencing (NGS) testing appropriate and plans to consider results in either first- or second-line therapy in the metastatic setting\n* A genomic tumor test has not been ordered or has been ordered but not resulted.\n\nExclusion Criteria:\n\n• Subjects with an active concurrent malignancy.",{"count":461,"type":22},500,[441],"This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for patients with stage IV solid tumor malignancies (breast, lung, colorectal, and bladder cancers).\n\nThe purpose of this study is to investigate whether intervention from a centralized precision oncology navigator and expert review of NGS results by the precision oncology pharmacist will increase ordering of Level 1\u002F2 genome informed therapy (GIT) compared to an estimated historical rate of 15%. Secondary endpoints will assess the impact of a centralized precision oncology navigator and expert review of NGS results on enrollment in biomarker-directed clinical trials and overall survival at 2 years after return of NGS results. The study will take approximately 12 months for enrolment and 2 years of follow-up after the date of NGS results.",[465,30,140,81,207,128],"Solid Tumor Malignancies",[467,468,469,470,471,472],"next-generation sequencing (NGS)","expert review of NGS","precision oncology","precision oncology navigator","genome informed therapy (GIT)","biomarker-directed clinical trials","2026-07-10",{"date":444,"type":37},{"date":476,"type":37},"2025-06-27",{"date":351,"type":22},{"name":479,"class":66},"UNC Lineberger Comprehensive Cancer Center",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":23,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":497,"locationsCount":67},"100454946","phase-1-actinium-225-labeled-anti-cea-antibody-ac225-dota-m5a-for-the-treatment-of-cea-producing-advanced-or-metastatic-cancers-100454946","NCT05204147","Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA Producing Advanced or Metastatic Cancers","A Phase I Study of Actinium-225 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced or Metastatic Cancers","Inclusion Criteria:\n\n* Patients must have a histologic diagnosis of a malignancy that expresses CEA. If biopsies were performed at an outside facility, the histology must be reviewed and confirmed by the Department of Pathology at the City of Hope\n* Patients must have tumors that produce CEA as documented by either an elevated serum CEA above the institutional limit of normal or by immunohistochemical methods. Positive CEA immunohistochemical staining, for the purposes of this protocol, is graded 0-3 and the percentage of tumor cells positive is estimated. A positive CEA stain is determined if more than 30% of the tumor cells have an intensity of 2+ or greater\n* Patients must have an advanced disease for which no standard or effective treatment is available. Patients who refuse a standard but non-curative treatment is available may also be considered\n* Karnofsky performance status \\>= 60% and an estimated survival of at least 3 months\n* Patients must be \\>= 18 years old as phase I data for the antibody is not available for younger patients.\n* The effects of Ac-225-DOTA-M5A on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately\n* Adequate bone marrow function as evidenced by white blood count (WBC) \\>= 4000\u002Ful, absolute neutrophil count \\>= 1500\u002Ful, platelet count \\>= 125,000\u002Ful are required\n* Adequate renal function as evidenced by a creatinine =\\\u003C 1.5 mg\u002Fdl and\u002For a calculated creatinine clearance \\>= 60 cc\u002Fmin\n* Adequate liver function as evidenced by bilirubin =\\\u003C 1.5 mg\u002Fdl and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no greater than 2 times the upper limit of normal. Less than 1\u002F3 of the liver must be estimated to be involved with tumor\n* Presence of measurable disease is required for study entry\n* All patients must be seen in consultation by City of Hope Radiation Oncology and City of Hope Medical Oncology prior to entry onto this trial\n* All subjects must have the ability to understand and the willingness to sign a written informed consent\n* Prior radiotherapy, immunotherapy, or chemotherapy must have been completed at least 4 weeks prior to patient entry on this study (6 weeks if treated with mitomycin-c or nitrosoureas) and patients must have recovered from any expected side effects of prior therapy\n\nExclusion Criteria:\n\n* Patients should not have any uncontrolled illness including ongoing or uncontrolled active infection\n* Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy\n* Pregnant women are excluded from this study because Ac225-DOTA-M5A are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Ac225-DOTA-M5A, breastfeeding should be discontinued if the mother is treated with Ac225-DOTA-M5A\n* Patients with recurrent or progressive brain or leptomeningeal involvement with cancer. Patients that have had previous therapies for brain metastasis or leptomeningeal disease with demonstrated response or stable disease at least four weeks after therapy will be eligible for the trial\n* Patients who have received previous radiation to \\> 50% of their bone marrow\n* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study",{"count":364,"type":22},[25],"This phase I study tests the safety, side effects, and best dose of Ac225-DOTA-M5A in treating patients with CEA positive colorectal cancer that has spread to other places in the body (advanced). Ac225-DOTA-M5A is a humanized monoclonal anti-CEA antibody, linked to a radioactive agent called actinium 225. M5A attaches to CEA positive cancer cells in a targeted way and delivers actinium 225 to kill them.",[124,30],"2026-07-01",{"date":493,"type":37},"2026-07-06",{"date":495,"type":37},"2022-06-02",{"date":424,"type":22},{"name":498,"class":66},"City of Hope Medical Center",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":520},"100478322","ablative-radiotherapy-to-restrain-every-metastasis-safely-treatable-arrest-2-a-randomized-phase-iiiii-trial-100478322","NCT05508464","Ablative Radiotherapy to Restrain Every Metastasis Safely Treatable (ARREST-2): A Randomized Phase II\u002FIII Trial","ARREST2","Inclusion Criteria:\n\n* Age 18 or older\n* willing and able to provide informed consent\n* ECOG performance status 0-2\n* Life expectancy \\> or equal to 6 months\n* Histologically confirmed malignancy with evidence of metastatic disease on imaging\n* All sites of disease can be safely treated on a preliminary radiation plan\n* \\> or equal to 11 metastases (the primary tumor does not have to be controlled and can be included as a target if it can feasibly and safely be treated with SABR. If the primary tumor is treated, a minimum of 12 targets are required0 at least 11 metastases are required in addition to the primary tumor.)\n* Investigations required within 12 weeks of enrollment:\n* Brain: MRI is required for all patients with known untreated or previously treated brain metastases. MRI is strongly recommended for all tumor sites with a propensity to develop brian metastases.\n* Body: 18-FDG PET\u002FCT imaging is recommended, except for tumors where FDG uptake is not expected (e.g. prostate, renal cell carcinoma). PSMA-PET or choline-PET is recommended for prostate cancer. In situations where a PET scan is unavailable, or for tumors that do not take up radiotracer, a CT neck\u002Fchest\u002Fabdomen\u002Fpelvis and bone scan are required.\n* Liver: For patients with liver metastases, a diagnostic or simulation MRI is required to confirm the total number of metastases.\n* No plans for systemic therapy (i.e. chemotherapy, targeted agent, immunotherapy) for 3 months from the time of enrolment. Reasons may include: a break from systemic therapy is desired by the patient and medical oncologist, the patient declines next line of systemic therapy, or no further systemic therapy options are available. Exceptions include hormone therapy for breast cancer or prostate cancer, which may be continued.\n* SABR or palliative radiotherapy should commence no later than 2 weeks after randomization.\n* For patients with brain metastases that are going to be treated regardless of the study arm, there must be additional extracranial disease present that will be treated with SABR on Arm 2 and not treated with SABR on Arm 1.\n\nExclusion Criteria:\n\n* Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Chrohn's disease in patients where the GI tract will receive radiotherapy, ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.\n* For patients with liver metastases, moderate\u002Fsevere liver dysfunction (Child-Pugh B or C)\n* Substantial overlap with a previously treated radiation volume. Prior radiotherapy is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biologically effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. All such cases must be discussed with the study PI.\n* Inability to treat all sites of disease. Any brain metastasis \\>3 cm in size or a total volume of brain metastases greater than 30 cc.\n* Solitary or dominant brian metastasis requiring surgical decompression.\n* Radiologic evidence of spinal cord compression.\n* Disseminated disease, including leptomeningeal metastases, peritoneal metastases\u002Fcarcinomatosis, malignant pleural effusion, and lymphangitis carcinomatosis.\n* Pregnant or lactating women.",{"count":507,"type":22},138,[441],"This is a phase II\u002FIII international multicentre randomized trial. Patients will be randomized in a 1:2 ratio between the standard of care (Arm 1) and SABR (Arm 2) to all sites of disease. The study will start as a phase II trial with an opportunity to convert to a phase III trial. The objective of this trial is to determine the impact of SABR on overall survival, progression-free survival, quality of life, and toxicity in patients with polymetastatic disease.",[30],"2026-06-26",{"date":513,"type":37},"2026-06-29",{"date":515,"type":37},"2023-10-16",{"date":517,"type":22},"2034-01-01",{"name":519,"class":66},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",3,{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":191},"100542694","phase-3-combination-of-immune-checkpoint-in-locally-advanced-or-metastatic-msidmmr-esogastric-adenocarcinomas-100542694","NCT06346197","Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI\u002FdMMR Esogastric Adenocarcinomas","A Multicenter, Randomised, Comparative, Open-label Phase III Aiming to Compare the Survival of Patients With Locally Advanced or Metastatic MSI\u002FdMMR Esogastric Adenocarcinomas Treated by a Combination of Immune Checkpoint Inhibitors (Botensilimab + Balstilimab) Versus the Standard of Care (FOLFOX\u002FXELOX + Nivolumab)","CIME","Inclusion Criteria:\n\n* Male or female patient ≥18 years of age at time of informed consent form signature.\n* Patient with MSI-H\u002FdMMR, HER2 negativeadvanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5. Note :The claudin 18.2 status must be known and documented before inclusion.\n* Patient to be treated with a first line therapy for locally advanced\u002Fmetastatic disease.\n* No prior treatment with chemotherapy for locally advanced\u002Fmetastatic disease.\n\n  o Note - adjuvant or neoadjuvant chemotherapy is allowed providing that 6 months have relapsed between completion of adjuvant chemotherapy and recurrence.\n* Measurable disease (outside any previous irradiated field within the past 6 months) defined as at least one unidimensional lesion that can be accurately measured as ≥ 10 mm with CT scan according to RECIST V1.1 (Appendix 01).\n\n  * Note: Lesions intended to be biopsied should not be defined as target lesions.\n  * Note: previously irradiated lesions can be selected as target lesion only if recurrence\u002FPD is documented after RT.\n* Patient with PS ECOG 0 or 1 (Appendix 02).\n* Adequate hematologic and end-organ function, defined by the following laboratory test results:\n\nAbsolute neutrophil count ≥ 1.5 109\u002FL (without growth factor support within 14 d) Platelets ≥ 100 109\u002FL (without transfusion for platelets within 7 d) Hemoglobin ≥ 9 g\u002FdL (without transfusion within 7 d) Creatinine clearance according to CKD-EPI ≥ 30 mL\u002Fmin\u002F1.73 m2 Serum total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3 x ULN is acceptable) ASAT and ALAT ≤ 3 x ULN (or up to 5 x ULN in case of liver metastasis or hepatic infiltration)\n\n* Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary or metastatic tumor tissue (resection or biopsy) with an associated pathology report must be available. This tumor sample must meet the following quality\u002Fquantity control criteria: ≥30 % of tumor cells and a tumor surface area ≥ 5mm2 or biopsiable disease (see next inclusion criteria).\n* Tumor lesion visible by medical imaging and accessible to repeatable percutaneous or endoscopic sampling that permits core needle biopsy without unacceptable risk of a significant procedural complications, and suitable for retrieval of a minimum of 4 cores with a needle minimum diameter :16-gauge.\n\n  * Note 1: Fine needle aspirates, bone biopsies do not satisfy the requirement for tumor tissue.\n  * Note 2: Tumor lesions used for biopsy should not be lesions used as RECIST 1.1 target lesions unless there are no other lesions suitable for biopsy. If a RECIST target lesion is used for biopsy, the lesion must be ≥ 2 cm in longest diameter.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit (within 72 hours of first dose of study drugs) and must agree to use highly effective contraceptive measures starting with the Screening Visit through\n\n  * 9 months after the end of the treatment with oxaliplatin\n  * 6 months after the end of the treatment with fluorouracil\n  * 5 months after the end of the treatment with nivolumab or botensilimab or Balstilimab\n  * 6 months for capecitabine\n\n    * Highly effective contraception is defined in Appendix 03.\n\nNote Non-childbearing potential is defined as:\n\n1. ≥ 50 years of age and has not had menses for greater than 1 year.\n2. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.\n3. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.\n\n   * Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 6 months after the end of the treatment with oxaliplatine or 3 months after the last dose for other study treatments is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n   * Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per protocol.\n   * Patients must be covered by a medical insurance.\n\nExclusion Criteria:\n\n* Oesogastric cancer eligible to treatment with curative intent\n* Patients previously treated by anti-PD-1, anti-PD-L1, or anti-CTLA-4 or any other immunotherapy\n* Patients with surgery or radiotherapy within less than 4 weeks before C1D1\n* Patients with persistent AE Grade \\>1 related to previous anti-cancer treatment, except alopecia (all grades), laboratory value according to criteria I7.\n* Patients with: hypokalemia, hypomagnesemia, hypocalcemia less than normal\n* Patients with known prolongation QT\u002FQTc interval i.e. QT\u002FQTc interval longer than 450 msec for men and longer than 470 msec for women according to the inclusion ECG.\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.\n\nNote: Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:\n\n* Measurable disease, per RECIST v1.1, must be present outside the CNS.\n* The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.\n* Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).\n* There is no evidence of interim progression between completion of CNS-directed therapy and initiation of study treatment.\n* The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, neurosurgical resection within 21 days prior to initiation of study treatment.\n* The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted. A minimal wash-out period of 10days for corticosteroids is required.\n\n  * Patients with other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer), or with no evidence of disease for ≥ 2 years.\n  * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n  * of ILD or non-infectious pneumonitis requiring glucocorticoids.\n  * History of allogeneic organ transplant.\n  * Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n  * Patient with peripheral sensory neuropathy with functional impairment.\n  * Patients with clinically significant active heart disease or myocardial infarction within 6 months, history of uncontrolled or symptomatic cardiac disease.\n  * Patient with recent (within 7d before C1D1) or concomitant treatment with brivudine.\n  * Patient with complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng\u002FmL) or partial deficit in DPD (i.e. blood uracil level between ≥ 16 ng\u002Fml and \\\u003C 150 ng\u002FmL)\n  * Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n  * Patient with Live vaccines injection within 4 weeks before C1D1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.\n  * Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).\n  * History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n  * Patients with documented:\n* Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) unless their HBV is stably controlled on nucleoside analogs (eg entecavir or tenofovir) which will be continued for the duration of the study. Note: Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to C1D1.\n* Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or\n* HIV infection\n\n  * Prior organ or bone marrow transplant.\n  * Pregnant or lactating women.",{"count":530,"type":22},132,[532],"PHASE3","CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H\u002FdMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX\u002FXELOX + nivolumab : standard arm).",[134,535,30,124],"MSI-H","2026-06-23",{"date":538,"type":37},"2026-06-25",{"date":540,"type":37},"2025-12-08",{"date":542,"type":22},"2028-05-15",{"name":544,"class":66},"Centre Leon Berard",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":18,"minAge":553,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":317,"phases":4,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":567},"100479659","kpmng-study-of-molecular-profiling-guided-therapy-based-on-genomic-alterations-in-advanced-solid-tumors-ii-100479659","NCT05525858","KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II","KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II","KOSMOSII","Inclusion Criteria:\n\n* 19 years of age or older\n* Histologically proven locally advanced or metastatic solid tumors\\*\\*\\* who showed disease progression on standard first line anti-cancer treatment and\u002For has no standard treatment option\n\n  \\*\\*\\* very rare diseases without standard treatment option which form solid mass, such as Erdheim Chester disease can be enrolled after KOSMOS MTB approval\n* A genomic test results must be available in a MFDS-accredited for laboratories offering service, or in part of clinical trial\u002Fstudy or other commercial labs approved and certified by regulatory bodies compatible with MFDS, such as CLIA. A genomic test can be conducted with tumor tissue as well as plasma circulating tumor DNA.\n\n  1. Results from genomic profiling tests performed after diagnosis with metastatic\u002Fadvanced disease to registration are acceptable. NGS results performed within three years prior to registration are preferred. Those patients with NGS results from primary tumor or more than 3 years prior to enrollment can be registered and whether NGS data is acceptable will be subject to MTB decision.\n  2. NGS panels should be i. Tested in a lab that is accredited by one or more quality assurance program (e.g., Korean Institute of Genomic Testing Evaluation, The Korean Society of Pathologists, Korean Society for Laboratory Medicine, Korea Laboratory Accreditation Scheme, etc.) ii. Patients who have insufficient genomic information from their NGS results (e.g., lack of variant calling format file or uninterpretable reports) or who are candidates of immunotherapy will submit their tissue and\u002For blood, for central NGS testing and exploratory biomarker analysis.\n* Ability to understand and the willingness to sign a written informed consent document\n* Life expectancy of at least 12 weeks\n* Adequate recovery from most recent systemic or local treatment for cancer.\n\nExclusion Criteria:\n\n* Patients receiving any anti-cancer treatment (local treatment, chemotherapy, immunotherapy, targeted therapy) within 2 weeks prior to the start of study treatment\n* Any clinical condition, according to the opinion of site physicians, which makes molecular profiling guided therapy not at the best interest of the participating patient.\n* Patients who have ongoing toxicities of ≥ CTCAE 2, other than peripheral neuropathy, related to previous anti-cancer treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE 3 will be excluded. Laboratory abnormalities ≥ CTCAE 2 considered as not clinically significant by the study physician will be allowed.\n* Pregnant or breastfeeding, or intending to become pregnant during the study","19 Years",{"count":555,"type":22},1000,"A national, prospective, multi-center, open-label, multi-cohort study comprised of a framework to screen patients for actionable targets and evaluation of molecular profiling guided therapy recommended by MTB based on genomic alterations using targeted and\u002For immunotherapies outside of the approved indications via local clinical practice (Tier 1 \\& 2) and clinical trials (Tier 3)",[82,29,30],"2026-06-17",{"date":560,"type":37},"2026-06-22",{"date":562,"type":37},"2022-09-28",{"date":564,"type":22},"2027-03",{"name":566,"class":66},"Seoul National University Bundang Hospital",32,{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":317,"phases":4,"briefSummary":578,"conditions":579,"keywords":580,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":67},"100522353","evaluating-disparities-in-precision-oncology-100522353","NCT06081517","Evaluating Disparities in Precision Oncology","Evaluating Disparities in Precision Oncology: An Observational Trial in the Context of a Real-World Academic Practice Model","EDPO","Inclusion Criteria:\n\n1. Ability to provide written informed consent and HIPAA authorization\n2. Patients must be ≥ 18 years old at the time of consent\n3. Patients who have or are planning to undergo molecular testing as part of their routine cancer care\n\nExclusion Criteria:\n\nN\u002FA",{"count":577,"type":22},10600,"This is a non-randomized observational trial designed to collect detailed clinical, social determinant, and genomic data from patients enrolled in molecular oncology tumor boards across four comprehensive cancer centers.",[30,124],[581,582],"Precision Medicine","Disparities","2026-06-12",{"date":585,"type":37},"2026-06-16",{"date":587,"type":37},"2024-01-26",{"date":589,"type":22},"2028-12",{"name":591,"class":66},"Indiana University",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":605,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":628},"100455246","phase-3-peak-a-phase-3-randomized-trial-of-cgt9486sunitinib-vs-sunitinib-in-subjects-with-gastrointestinal-stromal-tumors-100455246","NCT05208047","(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors","A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors","Key Inclusion Criteria:\n\n1. Histologically confirmed locally advanced, metastatic, and\u002For unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization. (GIST 1L Substudy: must have documented mutation in KIT Exon 9 with an available molecular pathology report; archival or fresh tumor tissue sample will be required)\n2. Documented disease progression on or intolerance to imatinib (Part 1a, Part 1b, Part 2, DDI Substudy)\n3. Subjects must have received the following treatment:\n\n   * DDI Substudy\u002FPart 1a: Treatment with ≥1 prior lines of therapy for GIST\n   * Part 1b: Treatment with ≥2 prior TKI for GISTs\n   * Part 2: Prior treatment with imatinib only\n   * GIST 1L Substudy: No prior systemic therapy for GIST including adjuvant therapy. Exception: up to 10 subjects with ongoing imatinib therapy of ≤4 weeks\n4. Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2, GIST 1L Substudy)\n5. Eastern Cooperative Oncology Group (ECOG) Status\n\n   * 0 to 2 (Part 1a, Part 1b, Part 2, DDI Substudy)\n   * 0 to 1 (GIST 1L Substudy)\n6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits\n\nKey Exclusion Criteria:\n\n1. Known Platelet-Derived Growth Factor Receptor (PDGFR) driving mutations or known succinate dehydrogenase deficiency (Part 1a, Part 1b, Part 2, DDI Substudy)\n2. Clinically significant cardiac disease\n3. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug (Part 1a, Part 1b, Part 2, DDI Substudy)\n4. Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption\n5. Any active bleeding excluding hemorrhoidal or gum bleeding\n6. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.\n7. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening\n8. Received strong CYP3A4 inhibitors or inducers (Part 1a, Part 1b, Part 2, DDI Substudy)\n9. Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)",{"count":600,"type":22},482,[532],"This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 482 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for Gastrointestinal Stromal Tumors (GIST) and 2) evaluating the potential for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. This study also contains two substudies: 1) a drug-drug interactions (DDI) substudy will investigate the potential for CGT9486 to be a Cytochrome P450 (CYP)3A4 inducer in approximately 16 patients who have received at least one prior line of therapy for GIST and 2) a substudy intended to test the efficacy of bezuclastinib and sunitinib as first-line (1L) treatment of GIST in approximately 40 participants with KIT exon 9 mutations and no prior systemic therapy (with the exception of up to 10 subjects with ongoing imatinib therapy of ≤4 weeks).",[604,30],"Advanced Gastrointestinal Stromal Tumors",[606,607,608,609,610,611,612,613,614,615,616,617,618,619,620],"Sunitinib","Solid Tumors","Gastrointestinal Stromal Tumors","Gastrointestinal","KIT","Kinase Inhibitors","Growth Inhibitors","CGT9486","Unresectable","Metastatic","GIST","Bezuclastinib","PLX9486","Midazolam","Drug-drug interaction",{"date":585,"type":37},{"date":623,"type":37},"2022-04-14",{"date":625,"type":22},"2030-01",{"name":627,"class":44},"Cogent Biosciences, Inc.",126,{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":23,"phases":637,"briefSummary":638,"conditions":639,"keywords":659,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":684,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":520},"100491983","phase-2-e7-tcr-t-cell-immunotherapy-for-human-papillomavirus-hpv-associated-cancers-100491983","NCT05686226","E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers","A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically or cytologically confirmed metastatic or refractory\u002Frecurrent HPV-16+ cancer.\n2. Tumor and\u002For blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele as determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease as assessed by RECIST Criteria Version 1.1.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.\n7. Must have received prior first line standard therapy or have declined standard therapy.\n8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII).\n9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery.\n10. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n11. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n12. Seronegative for HIV antibody, hepatitis B antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for hepatitis C (HCV) RNA must be negative.\n13. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate transferase (AST) (SGOT)\u002Falanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability for the protocol.\n15. Participants must be able to understand and be willing to sign the written informed consent document.\n16. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.\n\nNote: Participants may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n2. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.\n4. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n5. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.\n6. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible.\n7. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n8. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n10. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n11. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n\n    Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.\n12. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n13. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.\n14. Current treatment with another investigational agent.",{"count":364,"type":22},[26],"This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.",[133,640,641,642,643,644,645,30,646,647,648,649,650,651,652,653,654,655,656,657,658],"Throat Cancer","Oropharynx Cancer","Anal Cancer","Vulva Cancer","Vaginal Cancer","Penile Cancer","HPV-Related Malignancy","HPV-Related Carcinoma","HPV-Related Cervical Carcinoma","HPV-Related Squamous Cell Carcinoma","HPV-Related Adenocarcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV-Associated Vaginal Adenocarcinoma","HPV-Related Adenosquamous Carcinoma","HPV-Related Endocervical Adenocarcinoma","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Penile Squamous Cell Carcinoma","HPV-Related Vulvar Squamous Cell Carcinoma","HPV Positive Rectal Squamous Cell Carcinoma",[660,661,662,663,664,665,666,667,668,669,670,671,672,673,674,675,676,677,678,679,680,681,682,683],"Chimeric antigen receptors (CAR-T)","Tumor infiltrating lymphocyte","TCR-T","immunotherapy","T cell","adoptive cell therapy","cellular therapy","gene therapy","human papillomavirus","HPV","E7","T cell receptor","TCR","E7 TCR","lymphocyte","cell therapy","cervical cancer","oropharyngeal cancer","anal cancer","vulvar cancer","vaginal cancer","penile cancer","tumor infiltrating lymphocytes (TIL)","TIL therapy",{"date":583,"type":37},{"date":686,"type":37},"2023-03-07",{"date":688,"type":22},"2027-01-01",{"name":690,"class":66},"Christian Hinrichs",{"id":692,"slug":693,"hasResults":12,"nctId":694,"briefTitle":695,"officialTitle":696,"acronym":4,"eligibilityCriteria":697,"healthyVolunteers":12,"sex":698,"minAge":19,"maxAge":4,"enrollmentInfo":699,"targetDuration":4,"studyType":23,"phases":701,"briefSummary":702,"conditions":703,"keywords":707,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":714,"startDateStruct":716,"completionDateStruct":718,"leadSponsor":719,"locationsCount":152},"100471748","phase-2-abiraterone-enzalutamide-or-apalutamide-in-castrate-sensitive-prostate-cancer-100471748","NCT05422911","Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.","A Phase 2 Randomized Study of Abiraterone Acetate, Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer","Inclusion Criteria:\n\n* Veterans must meet the following to be eligible to participate:\n* Be willing and able to provide written informed consent for the trial.\n* Age ≥18 years of age on day of signing informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without morphologic evidence of small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.\n* Have previously begun within 120 days of randomization or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).\n* Laboratory tests meet minimum safety requirements:\n\n  * Hepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN, Total bilirubin ≤1.5X upper limit of normal (ULN) \\[except for subjects with documented Gilbert's disease in which case total bilirubin not to exceed 10X ULN\\].\n  * Renal: Creatinine clearance ≥30 ml\u002Fmin or serum creatinine ≤1.8 mg\u002Fdl\n  * Hematological: Platelet count ≥100,000\u002Fmm\\^3; Hemoglobin \\>9 g\u002FdL; ANC \\>1 X10\\^9\u002FL\n  * Serum potassium \\>3 mEq\u002FL\n\nExclusion Criteria:\n\nSubjects with any of the following will not be enrolled:\n\n* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide or darolutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo).\n* Treatment with hormonal therapy (e.g., androgen receptor inhibitors other than bicalutamide, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone-targeting agents and GnRH agonist\u002Fantagonist therapy) within 4 weeks of randomization.\n* History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).\n* Patients who are receiving any other investigational agents concurrently.\n* Clinically significant heart disease as evidenced by New York Heart Association (NYHA) Class III-IV heart disease.\n* Child-Pugh Class B and C","MALE",{"count":700,"type":22},192,[26],"The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent and uniform across the US. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.\n\nBut with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, all men with prostate cancer fare comparably well. As our sophistication in categorizing cancers molecularly has increased this study will look to better examine any emerging differences across study participants.",[30,704,705,706],"Neoplasm, Prostate","Castrate-sensitive","Castrate-sensitive Prostate Cancer",[708,709,710,711,712,713],"YONSA","zytiga","enzalutamide","apalutamide","growth rate","doubling time",{"date":715,"type":37},"2026-06-15",{"date":717,"type":37},"2022-08-31",{"date":262,"type":22},{"name":720,"class":44},"Sun Pharmaceutical Industries Limited",{"id":722,"slug":723,"hasResults":12,"nctId":724,"briefTitle":725,"officialTitle":726,"acronym":4,"eligibilityCriteria":727,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":728,"targetDuration":4,"studyType":23,"phases":730,"briefSummary":731,"conditions":732,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":734,"lastUpdatePostDateStruct":735,"startDateStruct":737,"completionDateStruct":739,"leadSponsor":741,"locationsCount":743},"100445155","phase-1-mem-288-oncolytic-virus-alone-and-in-combination-with-standard-of-care-therapy-in-advanced-solid-tumors-100445155","NCT05076760","MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors","Phase I Study Evaluating MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors","Inclusion Criteria:\n\n1. Ability to understand and provide informed consent.\n2. Willingness and ability to comply with scheduled study visits and procedures.\n3. Adult men or women age ≥ 18 years.\n4. ECOG performance status of 0 or 1.\n5. Part 1A monotherapy: Advanced\u002Fmetastatic NSCLC, cSCC, Merkel cell, melanoma, TNBC, pancreatic cancer, or head and neck cancer.\n6. Parts 1B and 1C combination: Advanced\u002Fmetastatic NSCLC which has progressed following front-line anti-PD-1\u002FPD-L1 with or without concurrent chemotherapy.\n7. Per each tumor type shown below, the specific initial standard of care therapies after which the subjects with specific histologies must have progressed have been included. Subjects will have been treated with at least one or more than one line of therapy prior to enrollment in the study.\n\n   1. Non-small cell lung cancer (NSCLC)\n\n      Part 1A monotherapy\n      * Must have progressed on standard therapy, including platinum-based chemotherapy and checkpoint inhibitor therapy (combined or sequential).\n      * Patients with tumors that have known actionable molecular alteration such in EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on standard directed molecular therapy, and platinum-based chemotherapy.\n\n      Part 1B MEM-288 plus nivolumab combination\n      * Must have first progression more than (\\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy\n\n      Part 1C MEM-288 plus docetaxel combination must have either:\n      * first progression with anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy, or\n      * progressed following initial first line anti-PD-1 or PD-L1 monotherapy followed by 2nd line platinum chemotherapy (with or without continuation of their first line anti-PD-1 or PD-L1 therapy).\n   2. Cutaneous squamous-cell carcinoma (cSCC)\n\n      * Must have progressed on standard therapy, including platinum-based chemotherapy and\u002For checkpoint inhibitor therapy.\n   3. Merkel cell Carcinoma\n\n      * Must have progressed on standard checkpoint inhibitor therapy.\n   4. Melanoma\n\n      * Subjects must have received a BRAF inhibitor as monotherapy or in combination with other targeted agents for BRAF V600E mutant melanoma.\n      * Subjects must have received an anti-PD-1\u002F PD-L1inhibitor as monotherapy or combination with anti-CTLA-4 inhibitor or other therapies.\n   5. Pancreatic cancer\n\n      * Progression after systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine).\n   6. Triple negative breast cancer (TNBC)\n\n      * Prior treatment (for advanced, metastatic or (neo)adjuvant) must have included a taxane and\u002For anthracycline-based therapy.\n   7. Head and Neck Cancer\n\n      * Prior treatment requirement in the metastatic or unresectable locally advanced setting include:\n      * Subjects must have received a platinum containing chemotherapy regimen for treatment of primary tumor in locally advanced, or metastatic settings\n      * Subjects must have received an anti-PD-1\u002F PD-L1 as monotherapy or in combination with chemotherapy.\n8. Progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status), except for patients with pancreatic cancer.\n\n   a) Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).\n9. Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, must have been previously treated with an applicable tyrosine kinase inhibitor.\n10. Tumor lesion which is deemed feasible for biopsy and injection under CT or ultrasound guidance (based on size, location, and visibility) by an interventional radiologist, and patient willing and able to provide tissue from biopsy of this lesion. Injected tumor should be \\> 1 cm3 in volume and should not encase or be inseparable from vital structures such as major nerves or blood vessels.\n\n    a) For Part 1 monotherapy patients treated at the first dose level, the tumor for injection must be an accessible cutaneous, subcutaneous, or superficial lymph node lesion that is palpable.\n11. Measurable disease, as defined per RECIST version 1.1.\n12. Prior history of brain metastases are eligible, provided:\n\n    1. Brain metastases have been treated\n    2. Asymptomatic from the brain metastases\n    3. Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days before registration to study\n    4. Brain metastases are stable on pre-registration imaging\n    5. No evidence of leptomeningeal disease\n13. Life expectancy \\> 3 months.\n14. Adequate organ and marrow function as defined below:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 x 10\\^9\u002FL\n    2. Hemoglobin ≥90 g\u002FL (or ≥9 g\u002FdL)\n    3. Platelets ≥100 x 10\\^9\u002FL\n    4. Calculated creatinine clearance of \\>50 mL\u002Fmin using Cockcroft Gault equation\n    5. Total bilirubin ≤ 1.5 x institutional upper limit of normal\n    6. AST (SGOT) and ALT (SGPT) ≤2.5 x institutional upper limit of normal\n    7. If Alkaline Phosphatase ≥ 2.5 x institutional upper limit of normal, then AST and ALT must be ≤ 1.5 x institutional upper limit of normal\n15. Patients of childbearing age must not be pregnant and must use established contraceptive strategies:\n\n    1. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n    2. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n    3. Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding.\n2. Serious uncontrolled medical disorder, psychiatric condition or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.\n3. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), or significant traumatic injury, within 4 weeks prior to starting study treatment or has not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy are exceptions and patients can receive study treatment ≥1 week after these procedures.\n4. History of clinically significant noninfectious interstitial pneumonitis (i.e., limiting activities of daily living or requiring therapeutic intervention), including clinically significant radiation pneumonitis.\n5. Residual toxicity from prior anticancer therapy of grade 3 or greater (CTCAE v5.0), with the exception of alopecia.\n6. Concurrent use of other anticancer approved or investigational agents.\n7. Clinically significant, uncontrolled heart disease and\u002For recent cardiac event (within 6 months), such as:\n\n   1. unstable angina within 6 months prior to screening\n   2. myocardial infarction within 6 months prior to screening\n   3. history of documented congestive heart failure (New York Heart Association functional classification III-IV)\n   4. cardiac arrhythmias not controlled with medication\n8. Active autoimmune disease requiring disease modifying therapy (except vitiligo, Grave's, or psoriasis not requiring systemic treatment).\n9. Any form of active primary or secondary immunodeficiency.\n10. Receiving ≥10 mg daily prednisone (or equivalent).\n11. Prior malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical\u002Fdysplasia endometrial, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period.\n12. Active systemic infections requiring intravenous antibiotics.\n13. Prior therapy with anti-tumor vaccines or other immune-stimulatory antitumor agents (other than FDA approved and National Comprehensive Cancer Network \\[NCCN\\] recommended systemic therapies).\n14. Prisoners or subjects who are involuntarily incarcerated, or who are compulsorily detained for treatment of either a psychiatric or physical illness.\n15. Any unresolved grade 2 irAE (except adequately treated endocrine irAE).\n16. Any toxicity that led to permanent discontinuation of prior anti-PD-1\u002FPD-L1 immunotherapy.",{"count":729,"type":22},40,[25],"This is a multipart, open-label, multi-center dose escalation, dose expansion phase I clinical trial designed to evaluate the safety, tolerability, maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and preliminary efficacy of MEM-288 in patients with advanced solid tumors. Eligible subjects must have a tumor lesion(s) which is accessible for injection.\n\nThe dose escalation phase (Part 1A - advanced solid tumors) has completed and is closed to enrollment. This phase evaluated multiple doses of MEM-288 dosed via intratumoral injection once every 3 weeks to assess safety, tolerability, preliminary efficacy, and to determine the MTD.\n\nThe dose expansion phase has multiple parts for advanced NSCLC. Part 1B has completed after evaluation of MEM-288 dosed via intratumoral injection in combination with standard of care nivolumab dosed via intravenous injection.\n\nIn a separate dose expansion arm (Part 1C) that is open for enrollment, patients with advanced NSCLC will be randomized to receive either an initial priming dose of MEM-288 injected into an accessible lesion (s) alone (Day 1) followed by MEM-288 in combination with standard of care docetaxel every 3 weeks up to 6 doses or MEM-288 injected into an accessible lesion(s) in combination with standard of care docetaxel therapy Day 1 and every 3 weeks up to 6 doses.\n\nThe study rationale is that the oncolytic effect of MEM-288 combined with the presence of CD40L and type 1 IFN in injected tumors will provide a strong signal for DC-mediated T cell activation leading to generation of systemic anti-tumor T cell responses with broad specificity akin to what is observed in the abscopal effect.",[82,124,30,126,165,170,131,733,219,210],"Pancreatic Cancer","2026-06-09",{"date":736,"type":37},"2026-06-11",{"date":738,"type":37},"2022-04-21",{"date":740,"type":22},"2031-12",{"name":742,"class":44},"Memgen, Inc.",2,{"id":745,"slug":746,"hasResults":12,"nctId":747,"briefTitle":748,"officialTitle":748,"acronym":749,"eligibilityCriteria":750,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":751,"targetDuration":4,"studyType":317,"phases":4,"briefSummary":753,"conditions":754,"keywords":756,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":734,"lastUpdatePostDateStruct":766,"startDateStruct":767,"completionDateStruct":769,"leadSponsor":771,"locationsCount":67},"100381217","immune-resistance-interrogation-study-100381217","NCT04243720","Immune Resistance Interrogation Study","IRIS","Inclusion Criteria:\n\n* Patients with a histological or cytological diagnosis of solid malignancies, with at least one tumor lesion amenable to core needle biopsy and consent to such a procedure.\n* Patients must have progressed on immunotherapy (defined as anti-PD1\u002FPD-L1 antibodies given as monotherapy or as part of a combination therapy) as their most recent line of therapy. Patients will be classified into two groups: 1) those who benefitted from immunotherapy with either complete response (CR), partial response (PR) or prolonged stable disease (SD) lasting at least 6 months with subsequent progression or who had disease progression after at least 12 weeks from the last dose of immunotherapy in the adjuvant setting (i.e. acquired resistance), 2) those whose disease is primary refractory to immunotherapy with disease progression at their first on-treatment imaging, those who benefitted from immunotherapy with stable disease (SD) but progressed in \\\u003C6 months or those that had progressive disease earlier than 12 weeks from the last dose of immunotherapy in the adjuvant setting.\n* Patients must be of good performance status, ECOG 0-1, for subsequent anticancer therapy, with either standard treatment or within the context of a clinical trial.\n* Patients must be ≥ 18 years old.\n* Patients must have provided voluntary written informed consent.\n\nExclusion Criteria:\n\n* Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.\n* Any contraindication to undergoing venipuncture.\n* Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimens and interpretation of study results.",{"count":752,"type":22},100,"This is a prospective research study which will include patients who have progressed on immunotherapy as their most recent line of therapy. This study aims to characterize whether patients who fail to respond to immunotherapy versus patients who respond initially but after a period of time progress demonstrate different genomic, transcriptomic, epigenetic, immunophenotyping profiles. Patients will have a one-time fresh tumor biopsy. Serial blood samples (total amount of blood drawn may not exceed the lesser of 50 mL or 3 mL\u002Fkg in an 8 week period), archival tissue (if available) and one stool sample will be collected.",[80,82,30,755],"Immune Resistance",[757,758,759,760,761,762,763,764,765],"Molecular Profiling","Liquid Biopsy","Tumor Biopsy","Circulation Tumor DNA","Epigenetics","Microbiome","Radiomics","Immune Analysis","Immunohistochemistry",{"date":380,"type":37},{"date":768,"type":37},"2020-08-26",{"date":770,"type":22},"2027-06",{"name":772,"class":66},"University Health Network, Toronto",{"id":774,"slug":775,"hasResults":12,"nctId":776,"briefTitle":777,"officialTitle":777,"acronym":4,"eligibilityCriteria":778,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":779,"targetDuration":4,"studyType":23,"phases":781,"briefSummary":782,"conditions":783,"keywords":785,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":789,"lastUpdatePostDateStruct":790,"startDateStruct":792,"completionDateStruct":794,"leadSponsor":796,"locationsCount":67},"100410202","phase-1-imaging-of-solid-tumors-using-fap-2286-100410202","NCT04621435","Imaging of Solid Tumors Using FAP-2286","Inclusion Criteria:\n\n1. Age \\>= 18 years.\n2. Histopathologically confirmed solid tumors in one of the following cohorts:\n\n   a. Cohort 1 (n=11): measurable disease is not required for this cohort.\n\n   i. Agnostic to tumor type.\n\n   b. Cohort 2 (n=95): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases. Note: Presence of absence of metastatic disease for eligibility determination will be assessed by reviewing medical records. Screening imaging will not be conducted for this study.\n\n   i. Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate-resistant prostate cancer, bladder cancer, colon cancer, or other cancer type.\n\n   c. Cohort 3 (n=85): No evidence of metastatic disease as defined as the absence of RECIST 1.1 measurable disease or bone metastases. Note: Presence of absence of metastatic disease for eligibility determination will be assessed by reviewing medical records. Screening imaging will not be conducted for this study.\n\n   i. Participants can be imaged at initial staging with what is judged by the treating physician to be high risk disease and where the presence of metastatic disease would greatly impact treatment planning and prognosis. Participants may also be imaged after therapy (surgery, chemotherapy or radiation therapy) if in the determination of the treating physician or investigator there is a high risk of disease recurrence that would also impact treatment plan and\u002For prognosis.\n\n   ii. Pathologically confirmed head and neck cancer, bladder cancer, or other cancer type.\n3. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.\n2. Known pregnancy.",{"count":780,"type":22},191,[25],"This is a multi-arm prospective trial that evaluates the ability of a novel imaging radiolabeled agents to detect metastatic cancer in participants with solid tumors using a gallium 68 (68Ga-) or copper 64 (64Cu-) FAP-2286 tracer. FAP-2286 is a peptidomimetic molecule that that binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on cancer-associated fibroblasts, and has been shown to be present on a number of solid tumors.",[784,30],"Solid Tumors, Adult",[786,787,788],"PET","68Ga-FAP-2286","64Cu-FAP-2286","2026-06-02",{"date":791,"type":37},"2026-06-04",{"date":793,"type":37},"2020-12-14",{"date":795,"type":22},"2026-12-31",{"name":797,"class":66},"Thomas Hope"]