[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumor":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,299,0,25,[9,49,95,122,145,168,209,237,261,286,326,352,380,403,424,446,475,510,533,553,573,600,642,672,694],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100630569","nci-childhood-cancer-data-initiative-ccdi-led-pediatric-adolescent-and-young-adult-rare-cancer-registry-for-very-rare-solid-tumors-100630569",false,"NCT07489378","NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors","* INCLUSION CRITERIA:\n* History of newly diagnosed (within 1 year of diagnosis) very rare solid tumor (defined as an estimated 2 incident cases per million per year).\n* Age \\>= 1 month and \\\u003C= 39 years at the time of diagnosis.\n* Participants must have established care with a local treating physician.\n* Ability of the participant, parent\u002Fguardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Diagnosis of any of the following at any time:\n\n  * Ewing Sarcoma\n  * Osteosarcoma\n  * Rhabdomyosarcoma\n  * Diffuse midline glioma (H3K27 altered)\n  * Atypical teratoid rhabdoid tumor\n  * Pleuropulmonary blastoma\n  * Common adult cancers that occur in pediatric\u002FAYA populations (i.e., colorectal cancer, breast cancer)\n* The participant is unlikely to comply with the terms of the protocol.","ALL","1 Month","120 Years",{"count":20,"type":21},4000,"ESTIMATED","OBSERVATIONAL","Background:\n\nAll childhood cancers are rare, but some are called very rare. Very rare cancers are diagnosed in 2 or fewer out of 1 million people each year. Researchers want to gather data so they can learn more about these very rare cancers. They hope to use the data to develop future treatments.\n\nObjective:\n\nTo gather data for a registry of very rare cancers found in children, teens, and young adults.\n\nEligibility:\n\nPeople aged 1 month to 39 years newly diagnosed (within the past year) with a very rare cancer.\n\nDesign:\n\nParticipation will be by phone or email. No clinic visits are required.\n\nResearchers will look at the participant s medical records. They will ask for samples of tumor tissue that were already removed. They will use the samples for genetic testing. The results of these tests will be sent to the participant s own doctors.\n\nSome participants will be asked for saliva or cheek swab samples. They will receive a kit in the mail. They will spit into a tube or swab the inside of their cheek. They will mail the sample back to the lab.\n\nParticipants will fill out questionnaires once a year for 5 years. They will answer questions about:\n\nFamily history, such as other cancers in the family and their income, work, and education.\n\nDemographics, such as their gender, nationality, ethnicity, education, and work history.\n\nSymptoms and treatment for their cancer. This may include level of pain, and emotional and physical well-being.\n\nParticipants data will be added to a secure database for other researchers. Their data will be anonymous.",[25,26,27,28,29],"Very Rare Tumors","Very Rare Cancers","Other Solid Tumors","Solid Tumor","Pediatric Rare Tumors",[31,32,33,34,35],"Longitudinal Study","Registry","Patient Reported Outcomes","Family History","Molecular Characterization","RECRUITING","2026-08-20",{"date":39,"type":40},"2026-08-21","ACTUAL",{"date":42,"type":21},"2026-08-26",{"date":44,"type":21},"2037-04-01",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":75,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100639777","phase-1-a-first-in-human-study-of-hh160-in-patients-with-advanced-solid-tumors-100639777","NCT07623369","A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors","An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria\n\n1. Adults aged 18 to 75 years with signed informed consent.\n2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.\n3. At least 1 measurable lesion per RECIST v1.1.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.\n5. Adequate organ function based on protocol-specified laboratory criteria.\n\nKey Exclusion Criteria\n\n1. Active leptomeningeal disease or uncontrolled\u002Funtreated brain metastases.\n2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.\n3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage\u002Fhemoptysis.\n\nNOTE: Other eligibility criteria may apply.","18 Years","75 Years",{"count":5,"type":21},"INTERVENTIONAL",[61],"PHASE1","This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.",[28,64,65,66,67,68,69,70,71,72,73,74],"Non-small Cell Lung Cancer","Hepatocellular Carcinoma","Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Renal Cell Carcinoma","Endometrial Cancer","Cervical Cancer","Small-cell Lung Cancer","Triple Negative Breast Cancer","Urothelial Carcinoma","Gastroesophageal Adenocarcinoma",[76,77,64,78,65,79,66,80,81,67,68,82,69,70,71,72,83,73,74,84],"HH160","PD-1×CTLA-4×VEGF-A Antibody","NSCLC","HCC","CRC","GEA","RCC","TNBC","Ovarian Cancer","2026-08-19",{"date":39,"type":40},{"date":88,"type":40},"2026-06-11",{"date":90,"type":21},"2028-08",{"name":92,"class":93},"Huahui Health","INDUSTRY",3,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":59,"phases":103,"briefSummary":105,"conditions":106,"keywords":110,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100601379","phase-1-a-phase-12-trial-of-ter-2013-in-patients-with-solid-tumors-harboring-aktpi3kpten-pathway-alterations-100601379","NCT07109726","A Phase 1\u002F2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT\u002FPI3K\u002FPTEN Pathway Alterations","Key Inclusion Criteria\n\n* Metastatic or locally advanced, unresectable disease\n* No available treatment with curative intent\n* Presence of lesions to be evaluated per RECIST v1.1:\n\n  a. Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ function\n* Advanced solid tumor malignancy harboring an eligible AKT\u002FPI3K\u002FPTEN pathway alteration detected by a sponsor approved test\n\nKey Inclusion Criteria for TER-2013 monotherapy arms:\n\n* Histologically confirmed diagnosis of:\n\n  a. \\[For TER-2013 dose escalation\\]: solid tumor malignancy b. \\[For TER-2013 cohort expansion\\]: i. Cohort 1: ovarian cancer, cervical cancer, or squamous cell carcinoma of the head and neck, lung, or esophagus ii. Cohort 2: endometrial adenocarcinoma\n* Prior therapy:\n\n  1. \\[For TER-2013 dose escalation\\]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused\n  2. \\[For TER-2013 cohort expansion\\]: No more than 3 prior lines of treatment in the advanced setting\n\n     Key Inclusion Criteria for TER-2013 and fulvestrant combination arms\n* Histologically confirmed diagnosis of:\n\n  a. \\[For TER-2013 + fulvestrant dose escalation\\]: HR+\u002FHER2- advanced unresectable or metastatic breast cancer b. \\[For TER-2013 + fulvestrant cohort expansion\\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting\n* Prior Therapy:\n\n  a. \\[For TER-2013 + fulvestrant dose escalation\\]: Received treatment with an AI containing regimen (single agent or in combination) b. \\[For TER-2013 + fulvestrant cohort expansion\\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting\n\nKey Exclusion Criteria:\n\n* Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K\u002FAKT\u002FPTEN alteration\n* Clinically significant abnormalities of glucose metabolism\n* Active brain metastases or carcinomatous meningitis.\n* History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug\n* Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to interfere with the delivery, absorption, or metabolism of TER-2013\n* Prior therapy:\n\n  1. \\[For TER-2013 monotherapy escalation\\]: AKT inhibitor\n  2. \\[For TER-2013 monotherapy expansion\\]: AKT\u002FPI3K\u002FPTEN pathway inhibitor\n  3. \\[For TER-2013 + fulvestrant combination expansion\\]: AKT\u002FPI3K\u002FPTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria apply",{"count":102,"type":21},205,[61,104],"PHASE2","This is a Phase 1\u002F2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT\u002FPI3K\u002FPTEN pathway alterations.",[107,69,84,108,67,109,28,70],"Breast Cancer","Lung Squamous Cell Carcinoma","Esophageal Squamous Cell Carcinoma",[111,107,112,113],"AKT\u002FPI3K\u002FPTEN Alterations","Advanced Solid Tumors","HR+\u002FHER2-",{"date":39,"type":40},{"date":116,"type":40},"2025-09-23",{"date":118,"type":21},"2029-02-28",{"name":120,"class":93},"Terremoto Biosciences Inc.",18,{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":16,"minAge":129,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":59,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":94},"100493142","phase-1-apg-115-alone-or-in-combination-with-apg-2575-in-children-with-recurrent-or-refractory-neuroblastoma-or-solid-tumors-100493142","NCT05701306","APG-115 Alone or in Combination With APG-2575 in Recurrent or Refractory Neuroblastoma or Solid Tumors","A Phase Ib-ⅡClinical Study of APG-115 Alone or in Combination With APG-2575 in Recurrent or Refractory Neuroblastoma or Solid Tumors","Inclusion Criteria:\n\n1. Age ≥5 years for APG-115 monotherapy; age ≥12 years for APG-115 + APG-2575 combination.\n2. Relapsed or refractory neuroblastoma or solid tumors with no available or suitable standard therapy.\n3. Physical state score ≥ 50.\n4. Expected survival ≥ 3 months.\n5. There are target lesions (neuroblastoma) or measurable lesions (other solid tumors).\n6. Have adequate organ function.\n7. Fresh or archived tumor tissue samples should be provided prior to treatment. If none of these specimens are available, inclusion may be made after consultation with the sponsor.\n8. Fertile women (≥14 years of age or having menarche) must have a negative serum pregnancy test at the time of the screening visit and must not be breastfeeding or planning to become pregnant during the study period.\n9. A potentially fertile male subject (who has spermatoses) or female subject (ibid.) must agree to use effective contraception during the trial period and for 3 months after the trial ends (or is prematurely discontinued).\n10. Informed consent must be obtained before carrying out any study procedure specified in the test. For child subjects, the consent of the subject and one of the parent\u002Flegal guardian must be obtained.\n11. The ability to swallow research drugs.\n\nExclusion Criteria:\n\n1. Received biological therapy, chemotherapy, or other investigational drugs within 21 days prior to dosing.\n2. Received radiotherapy, minor surgery\u002Fminimally-invasive surgery; small-molecule targeted agents, short-half-life chemotherapeutic agents, or traditional Chinese medicines with anti-tumor indications within 14 days prior to study drug administration (or within 5 half-lives, whichever is shorter).\n3. Patients who, according to the investigators' judgment, did not recover sufficiently after surgical treatment. Patients who underwent major surgery within 21 days before receiving the study drug for the first time.\n4. Adverse events due to previous antitumor therapy (except grade 2 peripheral neurotoxicity and alopecia that the investigators judged to be of no safety risk) have not recovered (severity higher than grade 1 according to CTCAE version 5.0).\n5. Patients with active brain tumors or brain metastases.\n6. Active gastrointestinal diseases (e.g. Crohn's disease, ulcerative colitis, or short bowel syndrome) or other malabsorption syndromes that may affect drug absorption.\n7. A known hemorrhagic predisposition\u002Fdisease, such as a history of non-chemotherapy-induced thrombocytopenic bleeding within 1 year before first receiving the study drug; Have active immune thrombocytopenic purpura (ITP), active autoimmune hemolytic anemia (AIHA), or a history of platelet transfusion failure (within 1 year before first receiving the study drug); Severe gastrointestinal bleeding occurred within 3 months.\n8. Clinically significant cardiovascular disease, cardiomyopathy, myocardial infarction or history within 6 months prior to administration.\n9. Symptomatic active fungal, bacterial, and\u002For viral infections requiring systemic treatment.\n10. Unexplained fever \\> 38.5℃ within 2 weeks prior to initial administration (subjects with tumor-related fever, as determined by the investigator, could be enrolled).\n11. Received MDM2 inhibitors or BCL-2 inhibitors.\n12. Any other circumstances or conditions that the investigator considers the patient inappropriate for participation in the study.","5 Years",{"count":131,"type":21},100,[61,104],"An open, non-randomized Phase Ib-II trial of dose-escalation and cohorts expansion to evaluate the safety, pharmacokinetic profile and initial efficacy of APG-115 alone or in combination with APG-2575 in the treatment of recurrent or refractory neuroblastoma or solid tumors.",[135,28],"Neuroblastoma",[135,28,137],"APG-115",{"date":39,"type":40},{"date":140,"type":40},"2023-02-28",{"date":142,"type":21},"2027-12-31",{"name":144,"class":93},"Ascentage Pharma Group Inc.",{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":59,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":48},"100652623","clinical-applications-of-fapi-pet-in-solid-tumors-100652623","NCT07776899","Clinical Applications of FAPI PET in Solid Tumors","Clinical Applications of Novel FAPI PET in Diverse Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 80 years, regardless of gender.\n2. Participants with suspected, confirmed, or suspected recurrent solid tumors.\n3. Participants who agree to participate in this clinical trial and provide written informed consent.\n4. Participants with good compliance, who commit to adhering to the study procedures and cooperate with the full study process.\n5. No plans for pregnancy within 6 months.\n\nExclusion Criteria:\n\n1. Patients with severe medical conditions that, in the investigator's opinion, make them unsuitable for participation in this clinical study, including but not limited to: severe cardiopulmonary insufficiency, severe bone marrow suppression, and severe hepatic or renal insufficiency.\n2. Patients with claustrophobia, severe psychiatric symptoms, or impaired consciousness that precludes cooperation with the examination procedures.\n3. Patients who have received any anti-tumor therapy during the interval between the two PET imaging sessions.\n4. Pregnant or breastfeeding women.\n5. Patients with poor compliance.","80 Years",{"count":154,"type":21},200,[156],"NA","The study systematically evaluates the diagnostic performance of FAPI-RuiJ and FAPI-04 PET\u002FCT or PET\u002FMR in various solid tumor types, and is expected to provide a novel molecular imaging tool for early lesion detection, accurate staging, and recurrence surveillance in patients with solid tumors.",[28],"2026-08-17",{"date":37,"type":40},{"date":162,"type":40},"2026-07-02",{"date":164,"type":21},"2029-03-31",{"name":166,"class":167},"Ruijin Hospital","OTHER",{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":59,"phases":177,"briefSummary":179,"conditions":180,"keywords":185,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100311904","phase-4-dabrafenib-andor-trametinib-rollover-study-100311904","NCT03340506","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.","100 Years",{"count":131,"type":21},[178],"PHASE4","This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",[181,182,28,183,184],"Melanoma","Non Small Cell Lung Cancer","Rare Cancers","High Grade Glioma",[186,187,188,189,190,181,191,192,193,194,195,182,196,197,198,199,184],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","Metastatic Melanoma","Advanced Melanoma","Lung Cancer","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers",{"date":201,"type":40},"2026-08-18",{"date":203,"type":40},"2018-01-26",{"date":205,"type":21},"2032-12-28",{"name":207,"class":93},"Novartis Pharmaceuticals",33,{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":59,"phases":218,"briefSummary":219,"conditions":220,"keywords":221,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":94},"100560551","phase-1-safety-and-preliminary-efficacy-of-sa53-os-in-patients-with-locally-advanced-or-metastatic-solid-tumors-100560551","NCT06578624","Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2a, Open-Label Study of Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SA53-OS, an MDM2 Inhibitor, in Patients With Locally Advanced or Metastatic p53 Wild-Type Solid Tumors","Inclusion Criteria:\n\n* Tumor characteristics of participants in Phase 1\n\n  1. Histologically and\u002For cytologically confirmed diagnosis of advanced or metastatic solid tumor and\u002For non-Hodgkin lymphoma excluding primary central nervous system malignancy for which no standard effective treatment exists or where that treatment was declined. Participants with non-Hodgkin lymphoma should have failed ≥ 2 prior lines of systemic therapy prior enrollment.\n  2. Tumor p53 wild-type.\n* Tumor characteristics of participants in Phase 2a\n\n  1. Cohort A: Tumor p53 wild-type with histologically confirmed diagnosis of advanced or metastatic DD LPS (and MDM2 amplification); OR Cohort B: Tumor p53 wild-type in other solid tumor.\n  2. Measurable disease by RECIST 1.1.\n* 18 years old or older.\n* Resolution of clinically relevant toxicity-related to prior anticancer therapies prior to receipt of study treatment to Grade 1 or less.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants of childbearing\u002Freproductive potential must agree to use adequate birth control measures during the course of the trial and for at least 3 months after discontinuing study treatment.\n\nExclusion Criteria:\n\n* Anticipated need for major surgery and\u002For localized palliative radiation within the next 6 weeks\n* Active, untreated central nervous system metastases. Participants with brain metastases identified at Screening may be rescreened after the lesion(s) have been appropriately treated; participants with treated brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study enrollment, and off corticosteroids for at least 2 weeks before start of study treatment, and treated lesions should demonstrate no new growth on the re-screening scan.\n* Known HIV infection or active hepatitis B or C infection.\n* Thrombotic event requiring active and ongoing anticoagulation within the last 6 months prior to study treatment.\n* Myocardial infarction within the last 6 months prior to study treatment.\n* Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, congestive heart failure New York Heart Association (NYHA) Class III or IV related to primary cardiac disease, uncontrolled ischemic or severe vascular heart disease.\n* A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)\n* Known bleeding disorder (e.g., hemophilia, von Willebrand disease).\n* Conditions that may predispose to major bleeding (e.g., active GI ulcers, upper or lower GI bleedings in the last 6 months, significant hemoptysis in the last 6 months, tumor invasion of major vessels, etc.). Conditions that have been treated may be allowed if resolution of the risk is documented.\n* Use or indication for full dose anticoagulation or anti-platelet therapy including low dose aspirin.\n* Women who are pregnant or lactating.",{"count":217,"type":21},70,[61,104],"The objective of this study is to assess the safety, efficacy, and pharmacokinetics of SA53-OS in adult participants with refractory solid tumors.\n\nThe study is comprised of 2 parts: Part 1 called dose escalation, and Part 2a called dose expansion. This study starts with Part 1 where participants who are diagnosed with advanced or metastatic solid tumor cancers receive different doses of SA53-OS (starting with the lowest dose) to find the maximum tolerated dose (MTD) of SA53-OS. Once the MTD of SA53-OS is known, the study continues to Part 2a where participants who are diagnosed with dedifferentiated liposarcoma (DD LPS) or other solid tumor cancers will receive SA53-OS at the MTD.\n\nThe study drug, SA53-OS, will be administered for 3 consecutive days every 3 weeks as an oral solution for up to 2 years.",[28],[222,223,224,225,226,227,228],"p53 wild-type tumor","liposarcoma","MDM2 inhibitor","solid tumors","dedifferentiated liposarcoma (DD LPS)","p53","Advanced or metastatic solid tumors","2026-08-16",{"date":201,"type":40},{"date":232,"type":40},"2025-03-10",{"date":234,"type":21},"2028-12",{"name":236,"class":93},"Lamassu Bio Inc",{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":59,"phases":246,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100563484","phase-1-a-phase-12-open-label-multicenter-fih-study-to-evaluate-safety-tolerability-pk-and-anti-tumor-activity-of-yh42946-100563484","NCT06616766","A Phase 1\u002F2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946","A Phase 1\u002F2, Open-label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, PK and Anti-tumor Activity of YH42946 in Patients With Locally Advanced or Metastatic Solid Tumors With HER2 Aberration and EGFR Exon 20 Insertion","Inclusion Criteria:\n\n* ECOG performance status 0 or 1\n* Estimated life expectancy of at least 3 months\n* Patients who have progressed on or after all available standard therapies or for whom standard treatment is inappropriate\n* Mandatory provision of archived or fresh tumor tissue in quantity sufficient to allow for retrospective confirmation of HER2 aberration or EGFR mutation\n* A patient with a history of brain metastases must have had all lesions treated\n* Adequate organ function defined as all of the following:\n\n  * Adequate bone marrow function (within 1 week prior to first administration): Neutrophils≥1.5 x10\\*9 cells\u002FL (Criteria must be met without the use of Granulocyte-Colony Stimulating Factor (G-CSF) within last week prior to testing.); platelet count≥75 x10\\*9 cells\u002FL; Hb ≥9g\u002FdL (Criteria must be met without packed red blood cell (pRBC) transfusion within last week prior to testing.)\n  * Adequate hepatic function: Serum bilirubin≤1.5 x upper limit of normal (ULN), and serum transaminase (either aspartate transaminase (AST) or alanine transaminase (ALT)) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases (within 1 week prior to first administration)\n  * Adequate renal function: Serum creatinine ≤ 1.5 x ULN or Estimated glomerular filtration rate (eGFR) \\> 60 mL\u002Fmin per 1.73 m\\*2 according to the site's calculation method.\n  * Adequate Heart function: QTcF≤ 470 ms, LVEF≥ 50%\n  * Blood Coagulation: INR or Prothrombin time ≤ 1.5 X ULN, aPTT ≤ 1.5 X ULN\n\n\\[Dose Escalation part only\\]\n\n* Histologically or cytologically confirmed diagnosis of advanced, and\u002For metastatic non-hematologic malignancy\n* Documented HER2 aberration or EGFR mutation (HER2 mutation or EGFR exon 20 insertion, HER2 amplification or overexpression)\n\n\\[Dose Expansion part only\\]\n\n* Patients who have at least 1 measurable lesion\n* Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC HER2 exon 20 insertion (Cohort 1)\n\nExclusion Criteria:\n\n* Patient with symptomatic or progressive brain metastases\n* Known or suspected leptomeningeal disease (LMD)\n* Uncontrolled spinal cord compression\n* History of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks\n* History of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system\n* Medical, psychiatric, cognitive or other conditions that compromise the patients ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study\n* Any severe concurrent disease or condition (includes active infections, cardiac arrhythmia) that in the judgment of the Investigator would make study participation inappropriate for the patient\n* History of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis\n* History of a second primary cancer with the exception of\n\n  1. curatively treated non-melanomatous skin cancer,\n  2. curatively treated cervical or breast carcinoma in situ, or\n  3. other malignancy with no known active disease present and no treatment administered during the last 2 years\n* Infection with Human immunodeficiency virus (HIV) infection, or active chronic hepatitis B or chronic hepatitis C\n* Major surgery within 4 weeks prior to the first dose of study treatment",{"count":245,"type":21},201,[61,104],"The goal of this YH42946-101 is to evaluate the safety, Tolerability, Pharmacokinetics and anti-tumor activity of YH42946 in patients with locally advanced of metastatic solid tumors with HER2 aberration and EGFR exon 20 insertions.",[249,28],"NSCLC (Non-small Cell Lung Cancer)",[251],"YH42946-101","2026-08-13",{"date":159,"type":40},{"date":255,"type":40},"2024-10-02",{"date":257,"type":21},"2028-07-29",{"name":259,"class":93},"Yuhan Corporation",8,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":59,"phases":270,"briefSummary":271,"conditions":272,"keywords":273,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":285},"100548817","phase-1-safety-and-tolerability-study-of-gim-531-in-advanced-solid-tumors-100548817","NCT06425926","Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors","A Phase 1\u002F2, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of GIM-531 as a Single Agent and in Combination With Anti-PD-1 in Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Written informed consent\n* Cytologically or histologically confirmed locally advanced or metastatic solid tumor that has progressed on standard therapy or for which no standard therapy exist; or be intolerant of standard therapy\n* Have not received an experimental drug within 4 weeks or 5 half-lives (whichever is shorter) of study drug treatment or already be enrolled in a clinical study\n* ECOG performance status 0-1\n* Laboratory and ECG assessments within 28 days of enrollment including acceptable cardiac, renal, and hepatic functions\n* Agree to baseline core needle biopsy or archival (within 12 months of screening) tumor submission; Note: Participants whose only site(s) of disease are in areas considered moderate or high risk for biopsy complications may be enrolled without a fresh biopsy upon Sponsor approval.\n* Non pregnant participants; female participants of child bearing potential with non-sterile partners agree to use an effective form of contraception from the time of first dose of study drug (or 14 days prior to first dose for oral contraception) until 7 months after the last dose of study drug. Effective forms of contraception include hormonal (injection or oral), double barrier method, or intrauterine device. Non-sterile male participants with sexual partners of childbearing potential agree to use a barrier contraception method and agree to not donate sperm from the time of first dose of study drug until 4 months after the last dose of study drug.\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1\n\nPhase 1 Expansion Cohorts Specific Inclusion Criteria (in addition to above inclusion criteria):\n\n* NSCLC: Participants must have locally advanced\u002Funresectable or metastatic NSCLC. Participants must have received no more than 3 prior lines of therapy in the advanced\u002Fmetastatic setting.\n* TNBC: Participants must have locally advanced unresectable, recurrent, or metastatic TNBC. Participants must have received no more than 3 prior lines of therapy in the advanced\u002Fmetastatic setting.\n* Ovarian Cancer: Participants must have locally advanced unresectable, recurrent, or metastatic ovarian cancer. Participants must have platinum-resistant ovarian cancer defined as disease recurrence or within 6 months after the last administration of platinum-based chemotherapy. Participants must have received no more than 1 line of therapy after development of platinum resistance. Maintenance treatment with Poly(ADP-ribose) polymerase inhibitors (PARPi) or bevacizumab are not counted as separate lines of therapy.\n* Tumors with AKT3 mutation\u002Famplification: Participants must have a locally advanced unresectable, recurrent, or metastatic solid malignancy. Participants with known AKT3 mutation\u002Famplification based on next generation sequencing (NGS) performed per local standard of care.\n\nPhase 2 Specific Inclusion Criteria (in addition to above inclusion criteria):\n\n* Have confirmed unresectable Stage III or metastatic Stage IV cutaneous melanoma, NSCLC, or RCC that has radiographically progressed (as confirmed by imaging assessed by the Investigator) on an approved single-agent or combination anti-PD-1 therapy\n* Must have received the anti-PD-1 therapy containing regimen as the latest line of treatment and be eligible to restart or to continue anti-PD-1 therapy in combination with GIM-531\n* BRAF wild-type melanoma or RCC: Participants must have received no more than 2 prior lines of therapy in the advanced\u002Fmetastatic setting\n* BRAF (V600) mutant melanoma or NSCLC: Participants must have received no more than 3 prior lines of therapy in the advanced\u002Fmetastatic setting.\n\nKey Exclusion Criteria:\n\n* Ongoing \\>Grade 1 toxicity from prior therapy according to Common Terminology Criteria for Adverse Events v5.0 (Note: Grade 2 alopecia and Grade 2 sensory neuropathy are not exclusionary)\n* Has known leptomeningeal disease, spinal cord compression, or brain metastases, except participants with the following:\n\n  * Brain metastases that have been treated and are clinically stable for at least 4 weeks prior to the first administration of study drug; Note: Participants receiving steroids for brain metastases must be either off steroids or on a stable, or decreasing dose, of \\\u003C10 mg daily of prednisone (or equivalent) in order to be eligible for enrollment; and\n  * No ongoing neurological symptoms related to the anatomic location of the brain metastases.\n\nNote: Neurological symptoms that are considered sequelae to treatment for brain metastases are allowed.\n\n* Has known structural cardiac disease\n* Has known serious arrythmia, serious dysrhythmia, history of long QT syndrome, or clinically relevant cardiac conduction abnormalities\n* Has an active autoimmune disease that has required systemic treatment in the past 12 months (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* At time of screening, is receiving systemic steroid therapy (greater than or equal to 10 mg\u002Fday of prednisone or equivalent) or is taking any immunosuppressive therapy; Note: Use of topical, inhaled, nasal, or ophthalmic steroids is allowed.\n* Has active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)\n* Has a history of, or currently has, an acquired or primary (congenital) immunodeficiency;\n* Has had prior anti-cancer treatment with chemotherapeutic agents or immune modulating agents within \\\u003C4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study drug.\n* Has received a live vaccine within 30 days of first dose of study drug;\n* Has had or has planned major surgery within 2 weeks of the first dose of study drug;\n* Inability to swallow an oral dose of a medication (eg, oral capsules)\n* Is taking medications that are considered strong inducers or inhibitors of CYP2C8 or CYP3A4\u002F5, P-glycoprotein (P-gp), breast cancer resistant protein (BCRP), or sensitive substrates of P-gp and BCRP (Appendix C) that cannot be discontinued at least 1 week prior to first dose of study drug and for the duration of the study.\n* Is taking drugs that modify gastric pH, such as proton-pump inhibitors (PPIs) or H2 blockers. Antacids such as calcium carbonate or aluminum hydroxide-based products are permitted.",{"count":269,"type":21},117,[61,104],"GIM-531 is a first-in-class, orally bioavailable small molecule that is being developed for the treatment of advanced solid tumors as a single agent and rescue therapy. GIM-531 exhibits its primary effect through selective inhibition of regulatory T-cells (Tregs).",[191,28],[274,275,276],"PD-1 resistance","PD-1 resistant\u002Frefractory","AKT3",{"date":278,"type":40},"2026-08-14",{"date":280,"type":40},"2024-05-09",{"date":282,"type":21},"2027-11",{"name":284,"class":93},"Georgiamune Inc",11,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":59,"phases":295,"briefSummary":296,"conditions":297,"keywords":310,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":208},"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":294,"type":21},619,[61,104],"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).",[298,66,28,299,300,301,79,302,303,304,305,306,307,308,309],"Cancer","Locally Advanced Solid Tumor","Metastatic Cancer","WNT Pathway","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",[298,28,299,300,311,312,313,302,314,315,316,317,318],"WNT Pathway Activating Mutation (WPAM)","Colorectal Cancer (CRC)","Microsatellite Stable (MSS)","Hepatocellular Carcinoma (HCC)","Adenomatous Polyposis Coli (APC)","β-catenin","Beta-catenin","CTNNB1",{"date":159,"type":40},{"date":321,"type":40},"2023-05-23",{"date":323,"type":21},"2027-08-31",{"name":325,"class":93},"Parabilis Medicines, Inc.",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":16,"minAge":334,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":337,"conditions":338,"keywords":341,"overallStatus":343,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":48},"100652336","validation-of-the-g8-screening-tool-for-prognostic-assessment-of-frailty-and-early-mortality-in-elderly-individuals-with-cancer-prospective-cohort-study-in-brazil-100652336","NCT07773285","Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil","Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil - CORALINE (LACOG 0625)","CORALINE","Inclusion Criteria:\n\n1. Aged 70 or above\n2. Diagnosis of cancer (solid tumors)\n3. Metastatic or recurrent cancer (treatment-naïve) regardless of the interval from prior localized disease\n4. Intention to start first systemic line of therapy\n5. Be able to understand and provide informed consent (ICF).\n\nExclusion Criteria:\n\n1\\. Nonmelanoma skin cancer","70 Years",{"count":336,"type":21},250,"This is a prospective observational cohort study including 250 individuals aged 70 years or older newly diagnosed with solid tumors. In this non-interventional study, all patient contacts will be conducted via telephone or video call.\n\nAfter obtaining informed consent which will be conducted electronically, an initial telemedicine assessment will be performed. During this evaluation, sociodemographic and clinical data will be collected, and a Comprehensive Geriatric Assessment (CGA) will be conducted. The assessment will be performed by a trained professional using internationally recognized, validated instruments that are preferably culturally adapted to the Brazilian population. The G8 score will be calculated based on information collected at baseline. Additionally, medication use, the Charlson Comorbidity Index, Mini Nutritional Assessment, and self-rated health status will be recorded. The total G8 score ranges from 0 to 17, with higher scores indicating better health status (abnormal G8 score ≤14).",[28,339,340],"Metastatic Solid Tumor","Recurrent Solid Tumor",[342],"Metastatic or recurrent cancer","NOT_YET_RECRUITING","2026-08-12",{"date":85,"type":40},{"date":347,"type":21},"2026-09",{"date":349,"type":21},"2030-09",{"name":351,"class":167},"Latin American Cooperative Oncology Group",{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":359,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":59,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":379},"100610246","descanso-a-mental-health-intervention-for-depression-insomnia-and-fatigue-symptoms-in-latino-people-with-cancer-100610246","NCT07225088","DESCANSO, a Mental Health Intervention for Depression, Insomnia, and Fatigue Symptoms in Latino People With Cancer","DESCANSO\u002FREST (Depresión\u002FDepressed Mood, Cansancio\u002FFatigue, and Sueño\u002FSleep): A Trial Assessing Feasibility and Acceptability of an Intervention for Depressed Mood, Insomnia, and Fatigue Symptoms in Latino Cancer Patients","Provider Eligibility Criteria:\n\nParticipant eligibility will be determined by a self-report screener. Inclusion Criteria Self-Report Criteria\n\n* Mental health provider\n* Treats Latino cancer patients and\u002For survivors\n* Has at least 3 years of clinical experience providing psychosocial services to cancer patients and\u002For survivors\n* Able to read Spanish determined by the question: \"Can you read in Spanish? Yes\u002FNo\"\n\nPatient Eligibility Criteria:\n\nA patient cannot be considered eligible for this study unless ALL of the following conditions are met. Participant eligibility will be determined by an initial EMR review followed by a self-report screener.\n\nInclusion Criteria EMR Criteria\n\n* Documentation of Disease\n\n  o Pathologically confirmed solid tumor cancer (either most recent or new diagnosis)\n* Definition of Disease \\[or Measurable Disease\\]\n\n  o Diagnosed with stages I, II, or III\n* Prior Treatment\n\n  * Currently undergoing systemic therapy (chemotherapy, radiation therapy, and\u002For immunotherapy) or within the first year following completion of systemic therapy Self-Report Criteria\n  * Age ≥ 21 years\n  * Lives in mainland U.S. or Puerto Rico\n  * Identifies as Latino\u002Fa or Hispanic\n  * Reports Spanish as their preferred language\n  * Speaks Spanish \"Very well\" or \"Well\" as determined by the question: \"How well do you speak Spanish?\"\n  * Presence of fatigue and disturbed sleep determined by a score of ≥ 3 on the MD Anderson Symptom Inventory\n\nExclusion Criteria EMR Criteria\n\no In the judgment of the treating physician, protocol investigators, and\u002For study staff, presence of cognitive impairment (e.g., delirium or dementia) sufficient to preclude meaningful informed consent and\u002For study participation\n\nSelf-Report Criteria\n\n* History of comorbidities within the last 12 months associated with fatigue and poor sleep, including hypothyroidism or abnormal thyroid function, sleep apnea, chronic obstructive pulmonary disease, neuromuscular disease, alcohol or drug abuse\n* Pregnant or lactating, women only\n* Presence of suicidal risk determined by any affirmative response on the Columbia-Suicide Severity Rating Scale",true,{"count":361,"type":21},125,[156],"The purpose of this study is to improve ways of providing mental health support to Spanish-speaking Latino participants who have cancer and experience depression, insomnia, and fatigue. Investigators will test a special mental health intervention called DESCANSO\u002FREST (Depresión\u002FDepressed Mood, Cansancio\u002FFatigue, and Sueño\u002FSleep). The intervention can be delivered through telehealth.",[28,365],"Solid Tumor, Adult",[28,367,368,369,370,371],"Solid Tumor Stage I","Solid Tumor Stage II","Solid Tumor Stage III","Memorial Sloan Kettering Cancer Center","25-277","2026-08-11",{"date":344,"type":40},{"date":375,"type":40},"2026-01-23",{"date":377,"type":21},"2029-04",{"name":370,"class":167},7,{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":359,"sex":16,"minAge":387,"maxAge":388,"enrollmentInfo":389,"targetDuration":4,"studyType":59,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":402},"100492397","molecular-profiling-for-pediatric-and-young-adult-cancer-treatment-stratification-2-100492397","NCT05691608","MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2","MAPPYACTS2","Inclusion Criteria:\n\n* Patient referred for sequencing of the tumor within the FMG2025 or equivalent program and written consent for FMG2025 - Cancers et leucémies pédiatriques en échec de traitement or equivalent signed\n* Written informed consent for MAPPYACTS 2 (or non-opposition for retrospective clinical data collection) according to local or national regulations\n* Patient with confirmed solid tumor or leukemia which is relapsed or refractory to standard treatment and who is potentially eligible for an experimental treatment or an early phase clinical trial at the time of tumor sequencing\n* Planned tumor biopsy, surgical resection, bone marrow or blood sample or recently (possibly within the last 3 months) archived frozen tumor material available of the current recurrent or refractory disease\n* Patients aged ≤ 25 years at the time of initial diagnosis\n* Performance status and life expectancy \\> 3 months at the time of tumor sequencing that allows enrolment into an experimental trial\n* Patients affiliated with a Social Security Regimen or beneficiary of the same as per local regulatory requirements\n\nExclusion Criteria:\n\n* Any concurrent illness or laboratory abnormality that, in the opinion of the investigator, is likely to interfere with the interpretation of study results\n* Pregnant women","6 Years","25 Years",{"count":390,"type":21},1800,[156],"FMG2025 continues the previous efforts to propose treatment for patients based on the molecular characteristics of their tumor at treatment failure in cancer precision medicine trials within standard of care in France. However, whereas FMG2025 is a descriptive effort providing the basis for clinical decisions, MAPPYACTS 2 will translate these findings to clinical actions. The symbiosis is critical to advance patient care.\n\nSince 2012, the molecular profiling trials \"MOlecular Screening for CAncer Treatment Optimization\" (MOSCATO-01) and \"MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification\" (MAPPYACTS) have included pediatric and adolescent patients with recurrent or refractory malignancy that underwent on-purpose biopsy or surgical intervention. Whole Exome Sequencing of tumor and normal tissue and RNA Sequencing of tumor tissue have been applied to detect genomic alterations that could lead to an adapted targeted treatment. Furthermore, ancillary studies were associated exploring circulating tumor DNA, the immune contexture of tumors and developing Patient-Derived Xenografts (PDX).\n\nThe FMG2025 project transfers the molecular profiling of advanced pediatric cancers into a global approach that is now considered standard of care in France. Subsequent clinical recommendations and decisions will be made based on discussions with biologists, scientist and physicians in the molecular and clinical molecular tumor boards. Associated ancillary research studies and links to clinical interventional studies remain essential elements of the program to provide clinical, translational and basic research in order to improve scientific knowledge.\n\nThe program is articulated in two main parts that are closely interacting:\n\nFMG2025 - Cancers et leucémies pédiatriques en échec de traitement or equivalent international projects that cover the sequencing of tumor and blood samples and provide molecular reports.\n\nThe clinical study MAPPYACTS 2 that provides clinical and therapeutic discussions of the sequencing results and therapy recommendations via the clinical molecular tumor board (CMTB) reports. It collects molecular and comprehensive clinical data of the patients registered in FMG2025 or equivalent international projects and thereby constitutes the critical link to clinical interventional studies and its sponsors ensuring facilitated access to these trials. It also covers and coordinates ancillary research studies.\n\nDue to the delay in opening of the MAPPYACTS 2 trial, clinical and molecular data for patients whose tumors were sequenced within FMG2025 or equivalent and not included in MAPPYACTS 2 before CMTB or equivalent, will be collected retrospectively after a specific patient\u002Flegal representative information and will contribute to the endpoints of the trial as adequate.",[28,394],"Leukemia",{"date":252,"type":40},{"date":397,"type":40},"2022-09-09",{"date":399,"type":21},"2030-09-09",{"name":401,"class":167},"Gustave Roussy, Cancer Campus, Grand Paris",29,{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":59,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":48},"100622355","phase-1-phase-1b-trial-of-bms-986504-in-combination-with-olaparib-in-patients-with-mtap-loss-100622355","NCT07382544","Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss","Phase 1b Trial of Combined PRMT5 Inhibition With BMS-986504 and PARP Inhibition With Olaparib in Patients With Advanced Cancer With MTAP Loss","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. All patients must have a histologically confirmed advanced or metastatic solid tumor that has been refractory to standard therapy or are not eligible for standard therapy and have no alternative curative-intent treatment options at the time of patient enrollment. For the dose escalation, any solid tumor is eligible, but enrollment will be enriched for CCA and pancreatic cancer. For the pharmacodynamic expansion, patients must have histologically confirmed advanced or metastatic CCA or pancreatic cancer.\n3. Homozygous deletion of MTAP as detected by Clinical Laboratory Improvement Amendmentscertified next-generation sequencing test or absence of MTAP protein as detected by CLIAcertified immunohistochemistry test.\n4. Patients in Part A must have archived tumor tissue available for retrospective analysis or agree to pre-treatment biopsy.\n5. Ability to understand and the willingness to sign a written informed consent document.\n6. Ability to comply with the study protocol, in the investigator's judgment.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 1).\n8. Life expectancy ≥3 months.\n9. Patients in the pharmacodynamic expansion must have measurable and biopsiable disease per the RECIST v1.1 (Appendix 2). Patients in the dose escalation can have evaluable or measurable disease.\n10. Patients must have adequate washout from prior therapy at the time of study treatment initiation: 3 weeks from any treatment specifically for systemic tumor control: 5 half-lives from small molecule targeted agents and ≥ 2 weeks from radiotherapy (except for patients with brain metastasis treatment with Gamma Knife; in these cases, \\> 1 week is required). Palliative radiotherapy is permitted for a preexisting lesion, provided it does not interfere with the assessment of tumor target lesions (e.g., the lesion to be irradiated must not be a site of measurable disease).\n11. Patients must have recovered from toxicities of prior anticancer therapy (Grade ≤ 1 toxicity) except for alopecia and peripheral neuropathy.\n12. Adequate organ and marrow function as defined below within 28 days prior to study treatment initiation:\n\n    * Hemoglobin ≥ 9.0 g\u002FdL\n    * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3\n    * Platelets ≥ 100,000\u002Fmm3\n    * Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL\u002Fmin\u002F1.73 m2 by the Chronic Disease Epidemiology Collaboration equation; estimated creatinine clearance ≥50 mL\u002Fmin (calculated using institutional standard method).\n    * Adequate hepatic function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Patients with Gilbert's syndrome with total bilirubin ≤ 2.0 × ULN and direct bilirubin within normal limits are permitted; Aspartate aminotransferase\u002FALT ≤ 3 × institutional ULN or ≤ 5 × ULN for patients with liver metastases.\n    * For patients not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen.\n13. Patients must be able to take PO medications.\n14. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result within 72 hours prior to study treatment initiation.\n\nWOCBP must agree to use adequate contraception as described below from the screening visit through at least 6 months after the last dose of study treatment. (Refer to Pregnancy Assessment Policy MD Anderson Cancer Center \\[MDACC\\] Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in ≥ 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range and have received whole pelvic radiation therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\nWOCBP must agree to use a combination of a hormonal and a non-hormonal contraceptive method or a non-hormonal method alone that is highly effective (with a failure rate of \\\u003C 1% per year: copper intrauterine device) during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for individual chemotherapy agents, whichever is longer.\n\nWOCBP are not permitted to use hormonal contraceptive methods alone as a highly effective method of contraception and must use an additional non-hormonal highly effective method of contraception.\n\nWOCBP must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period. Participants should be advised to seek advice about egg donation and cryopreservation of germ cells before treatment.\n\nExclusion Criteria:\n\n1. Part B only: Prior treatment with a PRMT5 or methionine adenosyltransferase 2A inhibitor.\n2. Patients who have a known additional malignancy that is progressing or requires active treatment at time of study treatment initiation. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.\n3. Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases. Note: Patients with stable brain metastases (defined as asymptomatic or no requirement for high-dose or increasing dose of systemic corticosteroids and without imminent need of radiation therapy) are eligible (including those with untreated brain metastases). If applicable, patients must have completed brain radiation therapy and recovered adequately from any associated toxicity and\u002For complications prior to eligibility assessment.\n4. Concomitant use of strong cytochrome P450 (CYP)3A inhibitors or inducers are prohibited within 14 days or 5 half-lives, whichever is longer, prior to study treatment initiation and during the study treatment period. For a comprehensive list of CYP3A inhibitors\u002Finducers, refer to: https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactionstable-substrates-inhibitors-and-inducers.\n5. Any clinically significant comorbidities such as uncontrolled pulmonary disease, known impaired cardiac function or clinically significant cardiac disease (including but not limited to known left ventricular ejection fraction \\\u003C 50%, congenital long QT syndrome, corrected QT interval using Fridericia's formula ≥ 480 msec on screening electrocardiogram \\[ECG\\], unstable angina pectoris ≤ 3 months prior to study treatment initiation, and acute myocardial infarction ≤ 3 months prior to study treatment initiation), or any other condition that could compromise the patient's participation in the study.\n6. Treatment with a live, attenuated vaccine within 4 weeks prior to study treatment initiation.\n\n   Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, Bacille Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Non-live COVID vaccines will be allowed on study, but it is recommended to avoid their use during the first treatment cycle (from 3 days prior to Cycle 1 Day 1 through Cycle 2 Day 3).\n7. Concomitant use of medications known to be sensitive substrates of breast cancer resistance protein (including, but not limited to, rosuvastatin and sulfasalazine) or P-glycoprotein (P-gp; including, but not limited to, dabigatran etexilate, digoxin, fexofenadine).\n8. Patients who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment.\n9. Any known psychiatric, substance abuse, or other disorder that would interfere with cooperation with the requirements of the study, in the opinion of the investigator.\n10. Patients who are receiving any other investigational agents.\n11. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.\n12. Patients who have an active infection requiring intravenous (IV) antibiotics.\n13. Patients with any gastrointestinal disorder that would significantly alter the absorption of the study drugs (e.g., active ulcerative diseases, uncontrolled nausea, uncontrolled vomiting, uncontrolled diarrhea, malabsorption syndrome).",{"count":411,"type":21},36,[61],"The goal of this clinical research study is to learn about the safety and effects of BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss.",[415,28],"Advanced Cancer","2026-08-10",{"date":344,"type":40},{"date":419,"type":40},"2026-02-12",{"date":421,"type":21},"2032-01-31",{"name":423,"class":167},"M.D. Anderson Cancer Center",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":59,"phases":433,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":438,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":445},"100577364","phase-1-a-study-of-pt0253-in-participants-with-kras-g12d-mutated-advanced-solid-tumors-100577364","NCT06797336","A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors","A Phase 1, Open-Label Dose Escalation and Expansion Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced or metastatic solid malignancy\n2. Participant has a pathologically documented, locally advanced or metastatic malignancy with KRAS p.G12D mutation identified through molecular testing using a Clinical Laboratory Improvement Amendments (CLIA) certified, validated institutional or commercial test.\n3. Measurable disease (RECIST 1.1 Criteria).\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n5. Willingness to avoid pregnancy or fathering children from screening through 90 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Active brain metastasis or carcinomatous meningitis. If participants have had brain metastases resected or have received radiation therapy, they may be eligible if: (1) study treatment begins at least 4 weeks from the end of brain-specific therapy, (2) residual neurological symptoms Grade less than or equal to (\\\u003C=) 2, (3) currently on stable doses of corticosteroids, and (4) pre-study brain magnetic resonance imaging (MRI) documents no new\u002Fworsening brain lesions.\n2. History of any other malignancy within the past 2 years, except:\n\n   * Malignancy treated with curative intent and with no known active disease present \\>=2 years before enrolment and felt to be at low risk for recurrence by the investigator\n   * Basal or squamous cell carcinoma of the skin, in situ cervical cancer, early -stage endometrial cancer that has been definitively treated, superficial bladder cancer, Gleason 6\u002F7 treated prostate cancer, and ductal carcinoma in situ or lobular carcinoma in situ of the breast.\n3. Unresolved toxicities from prior anti-cancer therapies (Common Terminology Criteria for Adverse Events \\[CTCAE\\] grades \\>1), except for alopecia. Grade \\\u003C=2 toxicities from prior anti-tumor therapies that are considered irreversible may be allowed, provided that they are not described in the exclusion criteria AND the investigator and medical monitor are in agreement to proceed.\n4. Concurrent participation in another interventional clinical study.\n5. Treatment with anticancer medications or investigational drugs within 14-28 days or 5 half-lives (whichever is longer) before the first administration of study drug. Concurrent hormonal therapy for prostate or breast cancer is allowed.\n6. Significant cardiovascular disease within 6 months of starting study therapy.\n7. Active infection requiring antibiotics within 1 day of study treatment.\n8. Known HIV infection with a cluster of differentiation 4+ (CD4+) T-cell count less than (\\\u003C) 200 cells per microliter \\[\u002FmcL\\] and\u002For a detectable viral load per parameters of assay and\u002For on an anti-retroviral regimen containing a strong or moderate cytochrome (CY)P3A4\u002F5 inhibitor or inducer and\u002For on a new anti-retroviral regimen for less than 28 days prior to the initiation of study treatment.\n9. Known history of drug-induced liver injury; primary biliary cirrhosis; or ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension.\n10. Major surgery within 4 weeks of the start of study therapy or postoperative complications preventing the participant from adhering to protocol assessments and procedures.\n11. Known hypersensitivity to any of the products to be administered during dosing.\n12. Any disease or disorder that, in the opinion of the investigator, may compromise the ability of the participant to provide written informed consent and\u002For to comply with all required study procedures.\n13. Part 1a (Dose escalation): Use of a strong or moderate CYP3A4\u002F5 inhibitor or inducer, strong P-glycoprotein (P-gp) inhibitor or inducer or P-gp substrate.\n14. Use of multidrug and toxin extrusion protein 1 (MATE) or MATE2-K substrates that cannot be discontinued prior to the start of study treatment.\n15. Participants with laboratory values indicating inadequate hematology, hepatic, or renal function.\n16. Clinically significant abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (ECG) or baseline QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>=450 milliseconds (msec).\n17. Female participants who are pregnant or lactating\u002Fbreast feeding or who plan to breastfeed while on study through 28 days after receiving the last dose of study drug.\n18. Active hepatitis B virus (HBV) infection. Participants with resolved infection or who are on stable antiviral therapy are eligible.\n19. Active hepatitis C virus (HCV) infection. Participants who have completed definitive antiviral therapy with post treatment confirmation of eradication are eligible.",{"count":432,"type":21},240,[61],"The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and\u002For recommended Phase 2 dose(s) (RP2D) of PT0253 in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutated advanced solid tumors as monotherapy.",[28],[437],"KRAS",{"date":344,"type":40},{"date":440,"type":40},"2024-12-19",{"date":442,"type":21},"2027-06-16",{"name":444,"class":93},"PAQ Therapeutics, Inc.",15,{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":59,"phases":455,"briefSummary":456,"conditions":457,"keywords":458,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":474},"100556570","phase-1-smp-3124lp-in-adults-with-advanced-solid-tumors-100556570","NCT06526819","SMP-3124LP in Adults With Advanced Solid Tumors","An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n\\- Histologically or cytologically-confirmed cancer that is advanced, recurrent, or metastatic with the following origins, and whose disease progressed on standard therapy and for whom there are no alternative therapies that may confer overall survival benefit.\n\nFor patients in the Dose Escalation part:\n\n1. Platinum-resistant ovarian cancer\n\n   * Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features (serous and clear cell)\n   * Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy\n2. Triple negative breast cancer - ER- and PR-negative with HER2 negative\n\n   * HER2 negative is defined as one of the following: 0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines\n   * ER- and PR-negative is defined as \\\u003C 10% of cells expressing hormonal receptors by IHC, as per standard guidelines\n3. Squamous cell carcinoma of the anus\n\n   \\- Patient with locally advanced ineligible for surgery is allowed.\n4. Squamous cell carcinoma of the head and neck\n5. Non-small cell lung cancer (NSCLC: adenocarcinoma, large cell, and squamous cell carcinoma)\n6. Uterine serous cancer (recurrent or persistent)\n\n   For Patients in the Dose Expansion Part:\n7. Cohort A: PROC (same as above)\n8. Cohort B: TNBC (same as above)\n9. Cohort C: SCCA (same as above)\n\n   * ECOG performance \\\u003C\u002F= 2 at screening\n   * Recovered from any prior treatment related toxicities\n   * Adequate organ function as evidenced by:\n\na. Hemoglobin \\>\u002F= 9 g\u002FdL (transfusion or use of erythropoietin to obtain this are not permitted) b. Absolute neutrophil count \\>\u002F= 1500 uL (platelet transfusion not allowed to achieve this) c. Platelet count \\>\u002F= 100 x 10 (platelet transfusion not alled to achieve this) d. Bilirubin \\\u003C\u002F= 1.5 x ULN (or \\\u003C\u002F= 3.0 x if ULN if Gilbert's syndrome) e. AST and ALT \\\u003C\u002F= 3.0 x ULN (or \\\u003C\u002F= 5 x ULN if the liver has tumor involvement f. Calculated creatinine clearance \\>\u002F= 60 mL\u002Fmin using Cockcroft-Gault formula\n\n* Patient is non-fertile or agrees to use adequate methods of contraception or agrees to refrain completely from heterosexual intercourse during the study and for 6 months (for female and male patients alike) after the last dose of study intervention.\n* May be HIV positive if the following conditions are met:\n\n  1. CD4 + T-cell count \\>\u002F= 350 cells\u002FuL\n  2. HIV viral load \\\u003C 400 copies\u002Fml prior to enrollment\n  3. No history of acquired immunodefficiency syndrome (AIDS) defining opportunistic infections\n* Known hepatitis B infection mush have negative serum HbsAg. Patients with known hepatitis C virus infection must have a viral load below the limit of quantification Japan sites only: HBc antibody or HBsantibody tests should be performed if HBsAg is negative. If HBc antibody or HBs antibody tests are positive, HBV DNA quantitative tests should be performed to confirm that HBV DNA is negative.\n\nExclusion Criteria:\n\n* Patient has received prior treatment at any time with a cell cycle checkpoint inhibitor (eg, CHK1 and\u002For CHK2, WEE1, or ATR inhibition)\n* Patient has a known allergy or sensitivity to any component of SMP-3124LP, including the inactive ingredients\n* Patient has received treatment with systemic anticancer therapy, radiotherapy, or investigational therapy within 14 days prior to Study Cycle 1 Day 1. (Palliative radiotherapy with a limited field of radiation within 2 weeks will be permitted.)\n* Patient has undergone a major surgical procedure ≤ 28 days, or minor surgical procedure ≤ 7 days, prior to Cycle 1 Day 1\n* Patient has used strong CYP1A2 or 2D6 inhibitors within 14 days or 5 half-lives, whichever occurs first, prior to Cycle 1 Day 1 (examples of restricted CYP1A2 and CYP2D6, P-gp, and\u002For BCRP inducers, inhibitors, or substrates are presented in Table 16)\n* Patient has central nervous system metastasis or leptomeningeal disease\n* Prior or concurrent malignancy whose natural history or treatment would have a significant potential to interfere with the safety or efficacy assessments of the investigational regimen\n* Patient has an abnormal ECG that is clinically significant, including a corrected QT interval (corrected using Fridericia's correction formula \\[QTcF\\]) \\> 470 msec; and\u002For a history of Torsade de Pointes\n* Patient has a left ventricular ejection fraction \\\u003C 45% by echocardiogram (ECHO)\n* Patient has clinically significant cardiac disease including heart failure (eg, New York Heart Association, Class III or IV)\n* Patient has an active, uncontrolled, bacterial, viral, or fungal infection requiring parenteral antimicrobial within 1 weeks prior to Cycle 1 Day 1\n* Patient is pregnant (as evidenced by a positive serum or urine pregnancy test) or is breastfeeding. Female breastfeeding patients may be enrolled if they interrupt breastfeeding. Breastfeeding should not be resumed for at least 6 months after the last dose of study drug.\n\nFor sites in Japan only: In addition to the above, any patient deemed likely to be pregnant based on medical interview will be excluded from the study.\n\n* Patient with ovarian cancer\n\n  1. Has a history of bowel obstruction related to their underlying disease within 3 months prior to Study Day 1\n  2. Has platinum-refractory disease. Platinum refractory is defined as progression during platinum-based chemotherapy\n* Patient has any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with their participation in the trial or interfere with the interpretation of trial results\n* Patient is taking a prohibited medication at baseline.",{"count":454,"type":21},120,[61,104],"An Open-label, Phase I Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Preliminary Antitumor Activity of SMP 3124LP in Adults with Advanced Solid Tumors",[28],[459,460,461,462,463,464,465,466],"first in human","open label","platinum-resistant ovarian cancer (PROC)","Triple Negative Breast Cancer (TNBC)","Metastatic squamous cell carcinoma of the anus (MSCCA)","Squamous cell carcinoma of the head and neck (SCCHN)","non-small cell lung cancer (NSCLC)","uterine serous cancer",{"date":344,"type":40},{"date":469,"type":40},"2024-08-14",{"date":471,"type":21},"2029-05",{"name":473,"class":93},"Sumitomo Pharma America, Inc.",12,{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":59,"phases":484,"briefSummary":485,"conditions":486,"keywords":501,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":379},"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":483,"type":21},56,[61],"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.",[487,488,489,490,491,181,492,493,494,495,67,496,497,498,499,415,300,500,28],"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","HNSCC","Adnexal Carcinoma","Angiosarcoma","Cutaneous Neoplasm","Refractory Cancer",[487,488,489,490,181,492,493,494,495,67,496,497,498,499,415,300,500,502,370,503,28],"MQ710","22-278",{"date":344,"type":40},{"date":506,"type":40},"2023-05-04",{"date":508,"type":21},"2028-05-04",{"name":370,"class":167},{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":516,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":48},"100571407","mmp14mt1-mmp-targeting-bicyclic-peptide-probe-for-pet-imaging-in-solid-tumors-100571407","NCT06719856","MMP14(MT1-MMP) Targeting Bicyclic Peptide Probe for PET Imaging in Solid Tumors","Inclusion Criteria:\n\n1. Malignant melanoma, glioma, lung cancer, colon cancer, pancreatic cancer, gastric cancer, breast cancer, liver cancer, etc., confirmed by histopathology or cytology;\n2. age ≥18 and ≤75 years old, male or female;\n3. ECOG score 0 or 1;\n4. expected survival time ≥6 months;\n5. There was at least one measurable target lesion according to RECIST1.1 criteria, and biopsy could be performed within one month before and after PET scan, and the patient could provide 2-3 lesion tissue slides;\n6. Women of childbearing age (15-49 years) must have had a negative pregnancy test within 7 days before starting testing; Women and men of childbearing potential must agree to use effective contraception to avoid pregnancy during the study and for 3 months after the examination;\n7. patients recommended by clinicians to undergo PET\u002FCT examination for tumor staging;\n8. The subjects could fully understand and voluntarily participate in this experiment, and signed an informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes.\n2. Individuals known or suspected to be allergic to the investigational drug or any of its components.\n3. Individuals with significantly abnormal liver or kidney function: serum total bilirubin (TBIL) \\> 1.5 × 20 µmol\u002FL, or aspartate aminotransferase (AST) \\> 2.5 × 45 µmol\u002FL, or alanine aminotransferase (ALT) \\> 2.5 × 40 µmol\u002FL, or serum creatinine \\> 1.5 × 130 µmol\u002FL.\n4. Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.\n5. Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.",{"count":517,"type":21},30,"The objective of the study is to construct a noninvasive approach using 68Ga-labeled bicyclic peptide radiotracer to detect the matrix metalloproteinase 14 (MMP14, MT1-MMP) expression of tumor lesions in patients with solid tumors and to identify patients benefiting from MMP14 targeting treatment.",[28],[521,522,523,524],"solid tumor","MMP14","MT1-MMP","PET imaging","2026-08-09",{"date":372,"type":40},{"date":528,"type":40},"2025-01-01",{"date":530,"type":21},"2026-12-31",{"name":532,"class":167},"Peking University Cancer Hospital & Institute",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":59,"phases":542,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":94},"100647162","a-study-to-evaluate-the-safety-and-antitumor-activity-of-gs-1206-in-adults-with-solid-tumors-100647162","NCT07703878","A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors","A Phase 1 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GS-1206 in Adults With Solid Tumors","Key Inclusion Criteria:\n\n* All individuals must have a tumor with protocol-specified mutation as determined by local health-authority approved test.\n* For Part A (including backfill cohorts): Individuals with histologically confirmed advanced or metastatic solid tumors who have progressed following treatment in the advanced or metastatic setting known to confer clinical benefit, unless the individual refused, is intolerant to, or is not eligible for standard-of-care (SOC) treatment.\n* For Part B dose expansion, individuals with protocol-specified tumor types will be enrolled.\n\nKey Exclusion Criteria:\n\n* Use of any of the therapies listed below within the specified time frames:\n\n  1. Investigational drugs (drugs not marketed for any indication) within 28 days prior to Cycle 1 Day 1.\n  2. Anticancer biologic agent or immunotherapy within 28 days prior to Cycle 1 Day 1.\n  3. Anticancer chemotherapy or targeted approved small molecule therapy within 21 days prior to Cycle 1 Day 1, or 42 days for nitrosoureas or mitomycin.\n  4. Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started within 14 days prior to planned Cycle 1 Day 1 are not permitted. Exceptions: hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started at least 14 days prior to Cycle 1 Day 1.\n  5. Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal\u002Fbiliary stent, biopsy) within 28 days prior to Cycle 1 Day 1, and any toxicity or complications have recovered to Grade 1 or less.\n  6. Radiation therapy within 21 days prior to Cycle 1 Day 1. Exception: limited (eg, pain palliation) radiation therapy is allowed if any radiation associated toxicity is resolved to Grade 1 or less, and the radiation is not administered to a target lesion.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":541,"type":21},302,[61],"The goal of this clinical study is to learn more about the study drug GS-1206, including its safety, tolerability, and antitumor activity in adult participants with solid tumors.",[28],"2026-08-06",{"date":416,"type":40},{"date":548,"type":40},"2026-07-17",{"date":550,"type":21},"2029-09",{"name":552,"class":93},"Gilead Sciences",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":560,"targetDuration":4,"studyType":59,"phases":562,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":343,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":571,"locationsCount":48},"100650766","phase-1-a-study-of-si-b036-in-patients-with-locally-advanced-or-metastatic-breast-cancer-and-other-solid-tumors-100650766","NCT07753226","A Study of SI-B036 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic breast cancer and other solid tumors;\n6. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n9. Toxicity from prior antitumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the required criteria;\n12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal;\n13. Urine protein ≤1+ or ≤1000 mg\u002F24 h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and they must be non-lactating; all enrolled patients (both males and females) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion;\n15. The trial participant must be able and willing to comply with the protocol-specified visits, treatment plan, laboratory tests, and other study-related procedures.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, or similar treatments within 4 weeks or 5 half-lives prior to the first dose;\n2. Receipt of immunosuppressive drug therapy within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n5. Active autoimmune diseases and inflammatory diseases;\n6. Prior experience of ≥ Grade 3 toxicity related to anti-angiogenic therapy during previous anti-angiogenic treatment;\n7. Diagnosis of another solid tumor within 5 years prior to the first dose;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n9. Poorly controlled hypertension;\n10. Diabetes mellitus with poor glycemic control;\n11. History of interstitial lung disease (ILD) requiring steroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis;\n12. Concurrent pulmonary disease resulting in severe impairment of respiratory function;\n13. Active central nervous system metastases;\n14. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of SI-B036;\n15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n16. Positive for human immunodeficiency virus antibodies, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first dose of the study drug;\n18. Presence of pleural, abdominal, or pelvic effusion, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first dose of the study drug;\n19. Imaging findings suggesting tumor invasion or encasement of major thoracic blood vessels, pericardium, or heart;\n20. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to screening;\n21. History of fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose;\n22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n23. Pregnant or breastfeeding women;\n24. Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial.",{"count":561,"type":21},39,[61],"This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic breast cancer and other solid tumors.",[107,28],"2026-08-04",{"date":567,"type":40},"2026-08-07",{"date":569,"type":21},"2026-08",{"date":234,"type":21},{"name":572,"class":93},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":580,"enrollmentInfo":581,"targetDuration":4,"studyType":59,"phases":582,"briefSummary":583,"conditions":584,"keywords":587,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":598,"locationsCount":48},"100650699","trophoblast-cell-surface-antigen-2-trop-2-targeted-petct-in-recurrent-and-metastatic-thyroid-cancer-100650699","NCT07753499","Trophoblast Cell-Surface Antigen 2 (Trop-2) Targeted PET\u002FCT in Recurrent and Metastatic Thyroid Cancer","Trophoblast Cell-Surface Antigen 2 (Trop-2) Targeted PET\u002FCT in Recurrent and Metastatic Thyroid Cancer and Compared With 68Ga-FAPI PET\u002FCT","Inclusion Criteria:\n\n* Adult patients (aged 18 years or older);\n* Patients with a history of previously treated thyroid cancer, including DTC and HGFCTC following thyroidectomy with or without 131I therapy, MTC after thyroidectomy, or ATC; either (1) evidence of structural or suspicious lesions on standard of care imaging or (2) biochemical evidence of disease in the absence of structural findings, defined as elevated thyrotropin suppressed thyroglobulin (Tgon ≥1 ng\u002FmL after 131I ablation or ≥5 ng\u002FmL without ablation) with negative anti thyroglobulin antibodies (\\\u003C20 IU\u002FmL) for DTC and HGFCTC or elevated calcitonin (\\>10 pg\u002FmL) for MTC;\n* Patients who had scheduled both 68Ga-MY6349 and 68Ga-FAPI PET\u002FCT scans;\n* Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n* No other anticancer therapy within four weeks prior to PET imaging.\n\nExclusion Criteria:\n\n* Pregnant or lactating patients;\n* Patients with a second primary tumor;\n* The inability or unwillingness of the research participant, parent, or legal representative to provide written informed consent.","90 Years",{"count":454,"type":21},[156],"In this study, we comprehensively evaluated the clinical utility of Trop2 PET\u002FCT (68Ga-MY6349 PET\u002FCT) imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with those of 68Ga-FAPI PET\u002FCT. The primary objective of this study was to evaluate the patient-based sensitivity of 68Ga-MY6349 PET\u002FCT in detecting recurrent and metastatic thyroid cancer. The secondary objectives included its overall specificity, lesion-based diagnostic performance, comparative tumor uptake relative to 68Ga-FAPI PET\u002FCT, and the impact on clinical management.",[585,28,586],"Tumor","Thyroid Cancer",[585,588,589,590,591,592,593],"Thyroid cancer","TENIS","Trop-2","FAP","Diagnosis","PET\u002FCT",{"date":567,"type":40},{"date":596,"type":21},"2026-08-01",{"date":142,"type":21},{"name":599,"class":167},"The First Affiliated Hospital of Xiamen University",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":16,"minAge":608,"maxAge":56,"enrollmentInfo":609,"targetDuration":4,"studyType":59,"phases":611,"briefSummary":612,"conditions":613,"keywords":621,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":641},"100549997","phase-1-phase-i-trial-to-determine-the-dose-and-evaluate-the-pk-and-safety-of-lutetium-lu-177-edotreotide-therapy-in-pediatric-participants-with-sstr-positive-tumors-100549997","NCT06441331","Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors","A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).","KinLET","Key Inclusion Criteria:\n\n* Participants aged ≥ 2 years and \\\u003C 18 years\n* Confirmed diagnosis somatostatin receptor-positive (SSTR-positive) disease.\n* Tumor which is relapsed or is refractory to at least one line of previous therapy\n* Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample\n* Radioactivity uptake within the primary tumor or metastatic tumor sites measured by locally available SRIs ( 111In-based, 99mTc-based, or 68Ga-based SSTR single-photon emission computed tomography (SPECT)\u002F computed tomography (CT) or positron emission tomography (PET)\u002FCT imaging, which is higher than the liver uptake)\n* Participants must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria, excluding alopecia, stable treated electrolyte abnormalities on replacement and stable treated hypothyroidism) of all prior treatment modality prior to entering this trial\n* In case of sequential treatment followed by SoC or prior therapy, washout period applies before starting targeted RPT\n\nScreening Consent Participant\u002Flegal guardian is willing to sign a screening consent. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA\u002FEdotreotide, or excipients\n* Previous history of acute leukemia unless in remission for at least two years\n* Extensive bone\u002Fbone marrow involvement as per Investigator's judgement unless peripheral blood stem cells (PBSC) are available at a minimum of 2.5x106 CD34+ cells\u002Fkg\n* Patients who have received previous systemic targeted RPT\n* Previous treatment with metaiodobenzyl guanidine (MIBG) if the predicted overall exposure is expected to exceed 2 Gy (gray) to the bone marrow or 23 Gy to the kidney.\n* Previous treatment with external beam radiation therapy (EBRT) if the predicted overall exposure is expected to exceed more than 2 Gy to the bone marrow or 23 Gy to the kidney.\n* Previous treatment with oncologic immune vaccine or CAR-T cell therapy\n* Bulky disease in the CNS\n* Presence of severe renal, hepatic, electrolyte, cardiovascular, or hematological dysfunction\n* Participants who have received a live-attenuated vaccine up to four weeks prior to enrolment\n* Pregnant or breastfeeding women.\n* Other known malignancies.\n* Serious non-malignant disease.","24 Months",{"count":610,"type":21},20,[61],"The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to \\\u003C18 years of age with somatostatin receptor (SSTR)-positive tumors.",[614,615,616,28,617,618,619,620],"Somatostatin Receptor Positive","NETs","Lymphoma","CNS Tumors","Rhabdomyosarcoma","Peripheral Primitive Neuroectodermal Tumor","GIST",[622,623,624,616,625,626,627,628,629,630,631,632],"Pediatric","CNS tumors","Solid tumors","Somatostatin Receptor (SSTR)-positive Tumors","Lutetium Lu 177 Edotreotide","Targeted RPT","ITM","GEP-NET","Neuroendocrine tumors","Radiopharmaceutical Therapy","Childhood","2026-08-03",{"date":565,"type":40},{"date":636,"type":40},"2025-09-26",{"date":638,"type":21},"2034-04",{"name":640,"class":93},"ITM Solucin GmbH",6,{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":648,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":650,"targetDuration":4,"studyType":59,"phases":652,"briefSummary":653,"conditions":654,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":671},"100452820","phase-1-study-of-zanzalintinib-in-combination-with-immuno-oncology-or-other-agents-in-participants-with-solid-tumors-100452820","NCT05176483","Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors","A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology or Other Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors","STELLAR-002","Key Inclusion Criteria:\n\n* Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.\n* Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n* Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.\n\n  * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.\n* Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.\n\n  * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)\u002FProgrammed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.\n  * Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.\n* Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.\n\n  * Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.\n* Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).\n\n  * Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence \\\u003C 12 months from the end of last therapy.\n  * Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.\n* Expansion Cohort 5 (post enfortumab vedotin \\[EV\\] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.\n\n  * Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1\u002FPD-L1 inhibitor or ineligible for PD-1\u002FPD-L1 inhibitor.\n  * Prior receipt of platinum-based therapy allowed but not required.\n  * Prior therapy with other agents allowed but not required.\n* Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.\n\n  * No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.\n* Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and\u002For unresectable HCC that is not amenable to curative treatment or locoregional therapy.\n* Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score \\[TPS\\] 1-49%) and without prior systemic anticancer therapy for metastatic disease.\n* Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.\n* Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.\n* Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.\n* Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.\n\n  * Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma\n* Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.\n* Cohort 15 (mCRPC, post-ARPI, visceral metastases): Men with metastatic adenocarcinoma of the prostate.\n* Cohort 16 (Drug-drug interaction \\[DDI\\]):\n\n  * Participants with a solid tumor that is unresectable or metastatic and for which life prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n  * Able to swallow capsules or tablets.\n* For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.\n* For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.\n* Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and\u002For stable on supportive therapy.\n* Karnofsky Performance Status (KPS) ≥ 70%.\n* Adequate organ and marrow function.\n* Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.\n* Females of childbearing potential must not be pregnant at screening.\n\nKey Exclusion Criteria:\n\n* For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1\u002FPD-L1, Lymphocyte-activation gene 3 (LAG-3) and cytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.\n* 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.\n* Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.\n* Administration of a live, attenuated vaccine within 30 days prior to first dose.\n* Uncontrolled, significant intercurrent or recent illness.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 460 ms for females and \\> 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.\n* Participants with inadequately treated adrenal insufficiency.\n* Pregnant or lactating females.\n* Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.\n* For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.\n* For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.\n* For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.\n* For Cohort 7 (HCC):\n\n  * Documented hepatic encephalopathy (HE) within 6 months before the first dose.\n  * Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.\n  * Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.\n  * Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma\n* For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and\u002For trifluridine + tipiracil (TAS-102).\n* For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.\n* For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable \\[MSS\\], 2L+), and 11 (HNSCC):\n\n  * Troponin T (TnT) or I (TnI) \\> 2 × institutional upper limit of normal (ULN).\n* For Cohort 16 (DDI):\n\n  * Known hypersensitivity to midazolam, warfarin, omeprazole, or caffeine.\n  * History of major head trauma (with loss of consciousness) within the past year or minor head trauma (without loss of consciousness) within 3 months prior to first dose of study treatment on Day 1.\n  * Primary liver tumor.\n  * Unable to refrain from or anticipates the use of the following:\n\n    * Any drugs known to be inducers or inhibitors of CYP3A4, CYP2C9, CYP2C19, and\u002For CYP1A2 within 14 days before the first dose of study treatment on Day 1 through the DDI assessments on Day 20.\n    * Drugs that are contraindicated with midazolam, warfarin, omeprazole, and\u002For caffeine during the DDI assessment part.\n    * Caffeine-containing beverages, products, and foods at least 3 days prior to and 3 days after probe substrate cocktail administration on Day 1 and Day 16.\n\n      * Poor peripheral venous access.\n\nNote: Additional Inclusion and Exclusion criteria may apply.",{"count":651,"type":21},1394,[61],"This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) and in combination with docetaxel and prednisone in participants with advanced solid tumors. In addition, the study will evaluate the effect of multiple dose administration of zanzalintinib on the single-dose pharmacokinetics of sensitive CYP3A4, CYP2C9, CYP2C19, or CYP1A2 substrates in participants with advanced solid tumors.\n\nIn the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.",[655,656,657,28,314,658,312,659,660,661,662],"Renal Cell Carcinoma (RCC)","Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Urothelial Carcinoma (UC)","Non-small Cell Lung Cancer (NSCLC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Non-Clear Cell Renal Cell Carcinoma (nccRCC)","Drug-Drug Interaction (DDI)",{"date":664,"type":40},"2026-08-05",{"date":666,"type":40},"2021-12-14",{"date":668,"type":21},"2030-06-28",{"name":670,"class":93},"Exelixis",122,{"id":673,"slug":674,"hasResults":12,"nctId":675,"briefTitle":676,"officialTitle":677,"acronym":678,"eligibilityCriteria":679,"healthyVolunteers":12,"sex":16,"minAge":680,"maxAge":334,"enrollmentInfo":681,"targetDuration":4,"studyType":59,"phases":683,"briefSummary":684,"conditions":685,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":686,"lastUpdatePostDateStruct":687,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":692,"locationsCount":48},"100457607","phase-1-multi-tumor-associated-antigen-specific-t-lymphocytes-to-treat-patients-with-high-risk-solid-tumors-100457607","NCT05238792","Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors","Phase I Research Study Utilizing Allogeneic Multi Tumor-Associated Antigen-Specific T Lymphocytes to Advance the Care of Patients With High-Risk Solid Tumors","ATTACK","Inclusion Criteria:\n\n* Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma.\n* HLA type and match through at least one allele with antigen-specific activity.\n* Following conventional therapy: refractory disease, residual detectable disease, or relapsed disease.\n* Age \\>= 1 year and \\\u003C70 years\n* Patient or parent\u002Fguardian capable of providing informed consent.\n* No systemic corticosteroid exposure within 1 week of initiating protocol treatment.\n* Karnofsky\u002FLansky score of ≥50%.\n* For participant with history of total body irradiation (TBI), radiation to thorax, or treatment with cardiotoxic chemotherapy (anthracycline or equivalent): Left ventricular ejection fraction (LVEF) \\>50% OR left ventricular fractional shortening (FS) \\>27% (may be performed within the last 12 months, and after completion of such treatment\u002Fs)\n* Hemoglobin \\>7.0 g\u002FdL (level can be achieved with transfusion).\n* Direct bilirubin ≤2.5 mg\u002FdL or 3x ULN (whichever is higher).\n* Aspartate transaminase (AST)\u002FAlanine transaminase (ALT) ≤5 x the upper limit of normal for age.\n* Serum creatinine \\\u003C1.0 mg\u002FdL or 2x the upper limit of normal for age (whichever is higher).\n* Pulse oximetry of \\>90% on room air.\n* Respiratory rate:\n* \\\u003C30 breaths per minute for patients aged \\\u003C18 years\n* \\\u003C25 breaths per minute for patients aged ≥18 years\n* Respiratory rate may be repeated if initial value is thought to be temporarily abnormal. If repeated, 2 values should be obtained ≥30 minutes apart prior to protocol treatment to be eligible.\n* Twelve (12) weeks post last radiation dose to the mediastinum\u002Fchest with resolution of any respiratory symptoms.\n* Negative pregnancy test in female patient of childbearing potential.\n* Agree to use contraceptive measures during study protocol participation through 6 months post final TAAT infusion (for FOCBP).\n* Prior to cycle #1 only (requisite for receiving lymphodepleting chemotherapy):\n* Absolute neutrophil count (ANC) \\>1000 \u002Ful.\n* Platelet count \\>75,000 \u002Ful.\n\nExclusion Criteria:\n\n* Patients with uncontrolled infections. Uncontrolled infections are defined as bacterial, fungal, or viral infections with either clinical signs of worsening despite standard therapy. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n* For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to protocol treatment.\n* For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to initiating protocol treatment.\n* Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days prior to initiating protocol treatment.\n* Exposure to chemotherapy or immunomodulatory medications within the last 2 weeks prior to initiating protocol treatment.\n* Pregnant or lactating females.","1 Year",{"count":682,"type":21},24,[61],"This is an open-label phase I dose-escalation study to evaluate the safety of partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning with or without local tumor ablation for pediatric and adult patients with high-risk solid tumors due to the presence of refractory, relapsed and\u002For minimal residual detectable disease following conventional therapy (e.g., chemotherapy, surgery, radiation, autologous stem cell transplant, or targeted therapy).",[28],"2026-07-31",{"date":565,"type":40},{"date":689,"type":40},"2021-11-17",{"date":691,"type":21},"2029-10",{"name":693,"class":167},"Children's National Research Institute",{"id":695,"slug":696,"hasResults":12,"nctId":697,"briefTitle":698,"officialTitle":699,"acronym":4,"eligibilityCriteria":700,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":701,"targetDuration":4,"studyType":59,"phases":703,"briefSummary":705,"conditions":706,"keywords":707,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":708,"lastUpdatePostDateStruct":709,"startDateStruct":710,"completionDateStruct":712,"leadSponsor":714,"locationsCount":48},"100645281","early-phase-1-an-exploratory-study-of-personalized-cancer-vaccine-in-adjuvant-therapy-of-solid-tumors-100645281","NCT07680582","An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors","An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors","Key Inclusion Criteria:\n\n1. ≥18 years of age at time of informed consent\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1\n3. Life expectancy of ≥6 months\n4. Patient diagnosed with solid tumors and is receiving perioperative and\u002For adjuvant anti-cancer therapy, or patients with advanced solid tumors\n5. No evidence of disease progression per investigator within 28 days before the first dose of study intervention\n6. Sufficient organ function\n7. Female patients must meet both of the criteria: a) Surgically sterile, or postmenopausal for ≥2 years, or women of childbearing potential with a negative pregnancy test and willing to use effective contraception during the study and for at least 90 days after the last study dose. Use of progesterone-containing contraceptives is not permitted. b) Agree not to breastfeed during the study and for at least 90 days after the last study dose.Male patients must meet the following criteria:If not surgically sterile and potentially engaging in sexual activity that could lead to pregnancy, agree to use effective contraception during the study and for at least 90 days after the last study dose.\n\nKey Exclusion Criteria:\n\n1. For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously\n2. Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or superficial bladder cancer, carcinoma in situ of the breast, carcinoma in situ of the cervix, thyroid cancer\n3. Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.\n4. Presence of active infections\n5. History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment\n6. Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab.",{"count":702,"type":21},60,[704],"EARLY_PHASE1","The purpose of this study is to evaluate the safety and tolerability of ABO2109 in combination with toripalimab, and to evaluate the immunogenicity, pharmacokinetics, pharmacodynamics, as well as biomarker characteristics of the investigational cancer vaccine. In addition, the antitumor activity of ABO2109 will be assessed during both dose exploration and expansion stages, the accumulative data will support the clinical development of ABO2109.",[28],[166],"2026-07-30",{"date":633,"type":40},{"date":711,"type":40},"2026-06-09",{"date":713,"type":21},"2031-02-09",{"name":166,"class":167}]