[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumor-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumor-adult":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,92,0,25,[9,47,76,113,135,185,222,243,265,292,317,343,367,387,408,457,490,542,563,605,635,676,696,718,748],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100603705","phase-1-personalized-radiotherapy-for-individualized-treatment-strategies-and-monitoring-prism-100603705",false,"NCT07139990","Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)","Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types","PRISM","Inclusion Criteria:\n\nCohort A:\n\n* \\>=18 years old\n* Performance status ECOG 0-2\n* Extensive stage small cell lung cancer diagnosed by tissue biopsy within 180 days of registration.\n* Patient must be planned for or receiving standard of care chemoimmunotherapy.\n* Patient must have received no more than 3 cycles by time of study enrollment.\n* Able and indicated according to investigator to receive thoracic radiotherapy\n\nCohort B:\n\n* 18 years old\n* Diagnosis of solid tumor malignancy with MRI-defined brain metastasis lesions within 60 days of registration\n* Each brain metastasis lesion enrolled must be 2 - 5 cm, except brainstem lesions which may be 1.5 - 5cm in size.\n\nCohort C:\n\n* \\>=18 years old\n* Performance status ECOG 0-2\n* Histologically confirmed surgically resectable, high grade (FNCLCC grade 2 or 3), localized soft tissue sarcoma of the trunk or extremities that measures \\>5 cm in any direction as assessed by imaging\n* Eligible to receive immunotherapy\n\nCohort D:\n\n* \\>=18 years old\n* Performance status ECOG 0-2\n* Pathologically proven diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx\n* Clinical stage III\u002FIVA (AJCC 8th edition)\n* Disease must be deemed resectable by head and neck surgeon\n* Eligible to receive immunotherapy\n\nExclusion Criteria:\n\nCohort A:\n\n⨀ Prior thoracic Radiotherapy\n\nCohort B:\n\n* Prior whole brain Radiotherapy\n* Prior surgical resection or focal radiotherapy of a target brain metastasis\n* Leptomeningeal disease\n\nCohort C:\n\n* Unresectable or metastatic (nodal or distant) disease\n* Synchronous malignancy requiring chemotherapy or other intensive treatment\n* Locally recurrent soft tissue sarcoma\n* Prior immunotherapy\n* Pregnancy or breastfeeding\n\nCohort D:\n\n* Distant metastasis\n* Inability to undergo PET-CT for baseline staging\n* HPV-positive or p16-positive oropharyngeal cancer\n* Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable\n* Prior immunotherapy for the study cancer or for a remote cancer\n* Prior head and neck radiotherapy","ALL","18 Years",{"count":21,"type":22},105,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","To characterize feasibility, safety, and\u002For preliminary efficacy of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.",[28,29,30,31,32,33],"Small Cell Lung Cancer Extensive Stage","Brain Metastases","Solid Tumor, Adult","Thoracic Cancer","Sarcoma,Soft Tissue","HNPCC","RECRUITING","2026-08-12",{"date":37,"type":38},"2026-08-17","ACTUAL",{"date":40,"type":38},"2025-10-28",{"date":42,"type":22},"2032-09-01",{"name":44,"class":45},"University of Texas Southwestern Medical Center","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"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":56,"type":22},125,[58],"NA","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.",[61,30],"Solid Tumor",[61,63,64,65,66,67],"Solid Tumor Stage I","Solid Tumor Stage II","Solid Tumor Stage III","Memorial Sloan Kettering Cancer Center","25-277","2026-08-11",{"date":35,"type":38},{"date":71,"type":38},"2026-01-23",{"date":73,"type":22},"2029-04",{"name":66,"class":45},7,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100555019","phase-1-safety-and-efficacy-of-kls-1-monotherapy-in-malignant-neoplasms-100555019","NCT06506643","Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms","A Phase I\u002FII Open-label Multicenter Dose Escalation and Dose Expansion Study to Evaluate the Safety and Efficacy of KLS-1 as Monotherapy in Patients With Malignant Neoplasms","Inclusion Criteria:\n\nPhase I and Phase II - solid tumors cohorts\n\n1. Adult (male or female) aged ≥18 years.\n2. Signed informed consent prior to any study-specific procedures.\n3. Patients who are willing to make themselves available for the duration of the study and are willing to follow study procedures.\n4. Have a performance status on the Eastern Cooperative Oncology Group (ECOG) scale of:\n\n   Phase I - 0 or 1; Phase II - 0-2.\n5. Have an estimated life expectancy of ≥12 weeks.\n6. Have adequate organ function including:\n\n   a. Hematologic:\n   * ANC ≥1.5 x 109\u002FL\n   * Platelets ≥100 x 109\u002FL\n   * Hemoglobin ≥90 g\u002FL b. Hepatic:\n   * Albumin ≥30 g\u002FL\n   * Bilirubin ≤1.5 times upper limit of normal (ULN)\n   * ALT and AST ≤2.5 x ULN. If the liver has tumor involvement, AST and ALT ≤5 x ULN are acceptable.\n\n     c. Renal:\n   * Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m2 d. Blood coagulation:\n   * International Normalized Ratio (INR) or activated partial prothrombin time (aPTT) \\\u003C1.5 x ULN and \\> 0.8 x LLN lower limit of normal (LLN).\n7. Have discontinued all chemotherapy, investigational therapy, molecularly targeted therapy, and cancer-related hormonal therapy at least 30 days prior to study enrollment (6 weeks for mitomycin-C or nitrosoureas).\n8. Have discontinued biologic therapy and immunotherapy at least 21 days prior to study enrollment.\n9. Patients who have had radiation therapy must be fully recovered in the opinion of the investigator prior to enrolling on study.\n10. Are recovered or recovering from the acute adverse effects of any chemotherapy, biologic therapy, immunotherapy, molecularly-targeted therapy, cancer-related hormonal therapy, and investigational therapy (≤Grade 1 or baseline), with the exception of alopecia or Grade 2 neuropathy.\n11. Have received at least 1 but no more than 4 prior systemic therapies for CLL.\n12. Patients who have had surgery must be fully recovered in the opinion of the investigator prior to enrolling on study (but not less than 28 days for major surgery and 14 days for minor surgery).\n13. Female patients with reproductive potential must agree to use 2 forms of highly effective contraception during the study and for at least 3 months following the last dose of IMP. Sexually active male patients must use a barrier method of contraception (condom) during the study and for at least 3 months following the last dose of IMP.\n14. Females with child-bearing potential must have had a negative pregnancy test result ≤28 days prior to the first dose of IMP, as well as ≤1 day prior to the first dose of IMP.\n15. Patients must be, in the judgment of the investigator, appropriate candidates for experimental therapy, and no standard therapy would confer clinical benefit to the patients.\n16. Patients must have at least one lesion that is measurable by RECIST v.1.1.\n\nPhase I 17. Patients must have histologically proven evidence of any type of metastatic solid tumor (excluding primary brain tumor) that is evaluable and for whom no approved therapy with demonstrated clinical benefit is available or patients who are intolerant or have declined standard therapy.\n\nPhase II 18. Patients must have histologically proven evidence of a solid tumor that is locally advanced and\u002For metastatic and for whom no approved therapy with demonstrated clinical benefit is available or patients who are intolerant or have declined standard therapy as follows:\n\n1. Cutaneous melanoma\n2. Prostate cancer\n3. Pancreatic cancer\n\nPhase II - CLL cohort\n\n1. Adult (male or female) aged ≥18 years.\n2. Signed informed consent prior to any study-specific procedures.\n3. Patients who are willing to make themselves available for the duration of the study and are willing to follow study procedures.\n4. Subjects with confirmed diagnosis of per iwCLL 2008.\n5. Documented disease progression that meets at least one of the iwCLL criteria for requiring treatment.\n6. Measurable disease defined by either absolute lymphocyte count (ALC ≥ 5 x 109\u002FL) or nodal lesion by computed tomography (CT).\n7. Have a performance status on the Eastern Cooperative Oncology Group (ECOG) scale ≤ 2.\n8. Have an estimated life expectancy of ≥16 weeks.\n9. Have adequate organ function including:\n\n   a. Adequate hematologic function in the absence of transfusions (within 6 weeks prior to first dose of study medication) and independent of growth factor support for at least 7 days with the exception of pegylated G-CSF which requires at least 14 days, defined as:\n   * WBC ≥3.0 x 109\u002FL\n   * ANC ≥1.0 x 109\u002FL\n   * Platelets ≥50 x 109\u002FL or ≥ 25 × 109\u002FL if thrombocytopenia is related to CLL b. Hepatic:\n   * Albumin ≥30 g\u002FL\n   * Bilirubin ≤2 x ULN. Subjects with known Gilbert's Syndrome or disease-related hemolysis must have a total bilirubin ≤ 3 x ULN\n   * ALT and AST ≤2.5 x ULN. c. Renal:\n   * Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m2 d. Blood coagulation:\n   * International Normalized Ratio (INR) or activated partial prothrombin time (aPTT) \\\u003C1.5 x ULN and \\> 0.8 x LLN.\n10. Have discontinued all chemotherapy, immunotherapy, investigational therapy, biologic therapy, molecularly targeted therapy, and cancer-related hormonal therapy at least 30 days prior to study enrollment (6 weeks for mitomycin-C or nitrosoureas).\n11. Are recovered or recovering from the acute adverse effects of any chemotherapy, biologic therapy, immunotherapy, molecularly targeted therapy, cancer-related hormonal therapy, and investigational therapy (≤Grade 1 or baseline), with the exception of alopecia or Grade 2 neuropathy.\n12. The subject must also agree to pretreatment and on-treatment bone marrow aspirates.\n13. Have received at least 1, but not more than 3 prior lines of therapy according to current guidelines.\n14. Patients who have had surgery must be fully recovered in the opinion of the investigator prior to enrolling on study (but not less than 28 days for major surgery and 14 days for minor surgery).\n15. Female patients with reproductive potential must agree to use 2 forms of highly effective contraception during the study and for at least 3 months following the last dose of IMP. Sexually active male patients must use a barrier method of contraception (condom) during the study and for at least 3 months following the last dose of IMP.\n16. Females with child-bearing potential must have had a negative pregnancy test result ≤28 days prior to the first dose of IMP, as well as ≤1 day prior to the first dose of IMP.\n17. Patients must be, in the judgment of the investigator, appropriate candidates for experimental therapy, and no standard therapy would confer clinical benefit to the patients.\n\nExclusion Criteria:\n\n1. Have another tumor of another location except basal cell carcinoma.\n2. Have a history of organ transplant (e.g., heart, lungs, liver, bone marrow, or kidney).\n3. Females who are pregnant or breastfeeding.\n4. Have symptomatic human immunodeficiency virus (HIV) infection, known HIV positive test results or have chronic active hepatitis B or C (screening is not required).\n5. Positive COVID-19 test or signs of coronavirus infections.\n6. Have clinically significant cardiac disease including any of the following:\n\n   * A history of congenital long QT syndrome, symptomatic bradycardia, ventricular arrhythmia, uncontrolled atrial fibrillation, second- or third-degree heart block, or other conduction abnormality that in the opinion of the investigator would preclude safe participation in this study.\n   * Congestive heart failure (New York Heart Association Class ≥3).\n   * Unstable angina pectoris, acute myocardial infarction, or stroke ≤12 months prior to enrollment.\n   * QTcF prolongation \\>450 msec.\n7. Currently taking medication known to prolong the QT interval or induce TdP, which cannot be discontinued or substituted.\n8. Uncontrolled type 1 or 2 diabetes with high risk of hypoglycemia.\n9. Are a family member of the investigator or staff of the study site.\n10. Are currently enrolled in another interventional clinical study of an investigational therapy.\n11. Hypersensitivity to any components of KLS-1. Additional exclusion criterion for patients enrolled in Phase II to CLL cohort\n12. History of Richter's transformation or prolymphocytic leukemia.",{"count":84,"type":22},36,[25,86],"PHASE2","The goal of this clinical trial is to test the safety and preliminary efficacy of a new drug, KLS-1, in adults with different types of solid tumors and chronic lymphocytic leukemia (CLL). The main questions it aims to answer are:\n\n* To define Dose Limiting Toxicities (DLT) and maximum tolerated dose (MTD) of KLS-1\n* To select the recommended Phase II Dose (P2D) of KLS-1\n* To determine the single dose and multiple dose PK profile following IV administration of KLS-1\n* What is the safest and most effective dose of KLS-1?\n* Does KLS-1 show anti-tumor activity in patients?\n* To evaluate preliminary efficacy of KLS-1 in up to 4 cohorts of locally advanced or metastatic solid tumor (malignant melanoma, prostate cancer, pancreatic cancer), or CLL.\n* To evaluate 12-months progression-free survival (PFS) and duration of response (DOR) follow-up after the last dose of KLS-1\n\nParticipants will:\n\n* Receive KLS-1 through intravenous (IV) infusions in 21-day cycles.\n* Be monitored for side effects and improvements in their malignancy. Investigators will compare different doses of KLS-1 in the initial phase to find the best dose for Phase II. Once the P2D is defined, it will be tested in a larger group to see its effects on locally advanced or metastatic solid tumor (malignant melanoma, prostate cancer, pancreatic cancer) and CLL.",[89,30],"CLL",[91,92,93,89,94,95,96,97,98,99,100,101],"malignant melanoma","prostate cancer","pancreatic cancer","chronic lymphocytic leukemia","Zn","Zinc","KLS-1","Malignant Neoplasms","Neoplasms","Metastatic Tumors","Zinc Aspartate","2026-08-04",{"date":104,"type":38},"2026-08-05",{"date":106,"type":38},"2024-05-15",{"date":108,"type":22},"2029-12-31",{"name":110,"class":111},"Vector Vitale LLC","INDUSTRY",2,{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":46},"100615612","phase-1-a-study-of-til-in-advanced-solid-tumors-cz-100615612","NCT07294872","A Study of TIL in Advanced Solid Tumors (CZ)","A Study Study of Tumor Infiltrating Lymphocytes Injection (GC101\u002F203 TIL) in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* have one the tumor resection for TILs production and successfully produced；\n* Age: 18 years to 75years;\n* Histologically diagnosed as solid tumors;\n* Expected life-span more than 3 months;\n* ECOG score 0-1;\n* Test subjects have failed standard treatment regimens, and be willing to receive TIL therapy;\n* At least 1 evaluable tumor lesion;\n\nExclusion Criteria:\n\n* with other malignant tumors, except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;\n* Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n* Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \\\u003C 95%;\n* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;\n* Significant cardiovascular anomalies","70 Years",{"count":122,"type":22},30,[25],"This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.",[30],"NOT_YET_RECRUITING","2026-08-03",{"date":104,"type":38},{"date":130,"type":22},"2026-12-08",{"date":132,"type":22},"2029-09-20",{"name":134,"class":111},"Shanghai Juncell Therapeutics",{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":161,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100586467","phase-1-safety-and-preliminary-anti-tumor-activity-of-tyra-430-in-advanced-hepatocellular-carcinoma-and-other-solid-tumors-with-activating-fgffgfr-pathway-aberrations-100586467","NCT06915753","Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF\u002FFGFR Pathway Aberrations","A Multicenter, Open-label, First-in-Human Study of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF\u002FFGFR Pathway Aberrations","SURF431","Key Inclusion Criteria:\n\nAll Patients:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.\n* Adequate end organ function.\n* Ability to swallow oral formulations.\n* Ability to understand and willingness to sign the ICF.\n\nPart A:\n\n* Histologically confirmed locally advanced unresectable\u002Fmetastatic HCC or histologically confirmed advanced solid tumor with documented FGF\u002FFGFR pathway alterations\n* For participants with histologically confirmed locally advanced or metastatic HCC:\n\n  * Barcelona Clinic Liver Cancer (BCLC) stage B that is not eligible for locoregional therapy, or stage C.\n  * Child-Pugh Score class A\n* Must have previously received SOC appropriate for their tumor type. Any number of prior therapies, including FGFR inhibitors, are permitted.\n* Agree to provide archival tumor tissue no older than 2 years from the time of enrollment, if available. If an archived specimen is not available, a biopsy is not required.\n\nPart B, Cohort 1:\n\n* Histologically confirmed locally advanced\u002Fmetastatic HCC who have previously received standard of care.\n* Barcelona Clinic Liver Cancer (BCLC) stage B that is not eligible for locoregional therapy, or stage C.\n* Child-Pugh Score class A\n* Availability of an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen obtained ≤2 years prior to screening for submission to sponsor-designated central laboratory for FGF19 IHC testing.\n* At least 1 measurable lesion by RECIST v1.1.\n\nPart B, Cohort 2:\n\n* Histologically confirmed advanced solid tumor except FGFR3-altered urothelial carcinoma and primary central nervous system tumors who have previously received standard of care. Note: Participants with confirmed diagnosis of locally advanced or metastatic HCC are not eligible for Cohort 2.\n* Must have an eligible activating gain-of-function alteration in the FGFR3 or FGFR4 gene, or focal amplifications of FGF19\n* Archival tumor tissue biopsy specimen no older than 2 years from the time of enrollment, if available. If a tissue biopsy specimen is not available, a biopsy is not required.\n* At least 1 measurable lesion by RECIST v1.1.\n\nKey Exclusion Criteria:\n\nAll Patients:\n\n* Have disease that is suitable for local therapy administered with curative intent.\n* Have not recovered from reversible toxicity of prior anticancer therapy to \\\u003C Grade 1 or baseline (except toxicities that are not clinically significant or not expected to resolve, including but not limited to, alopecia, fatigue, skin discoloration, or Grade 1 neuropathy).\n* Have received the following anticancer therapy:\n\n  1. Any immunotherapy or other antibody therapy within 28 days prior to the first dose of the study drug.\n  2. A TKI \\\u003C 5 days or 5X the terminal Phase elimination half-lives, whichever is longer, prior to the first dose of TYRA-430.\n  3. Other systemic therapy not listed above \\\u003C 14 days prior to the first dose of the study drug.\n* Participant discontinued a prior anti-FGFR therapy due to significant toxicity, defined as hepatotoxicity ≥ Grade 3 or any Grade 4 toxicity according to CTCAE v5.0.\n* Has a serum phosphorus level \\> upper limit of normal (ULN) during screening that remains \\>ULN despite medical management.\n* History of or current uncontrolled cardiovascular disease.\n* Active, symptomatic, or untreated brain metastases.\n* Have a diagnosis of primary CNS malignancies.\n* Gastrointestinal disorders that will affect oral administration or absorption of TYRA-430.\n* Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.\n* Any reason that, in the view of investigator, would substantially impair the ability of the participant to comply with study procedures and increase the risk to the participant.\n\nPart B, Cohort 1:\n\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* Prior treatment with pan-FGFR inhibitors or FGFR4-selective inhibitors.\n\nPart B, Cohort 2:\n\n* Histologically confirmed locally advanced\u002Fmetastatic HCC.\n* Histologically confirmed urothelial cancer.",{"count":144,"type":22},100,[25],"A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary antitumor activity of TYRA-430 in cancers with FGF\u002FFGFR pathway aberrations, including locally advanced\u002Fmetastatic hepatocellular carcinoma and other advanced solid tumors.",[148,149,30,150,151,152,153,154,155,156,157,158,159,160],"Metastatic Hepatocellular Carcinoma","Solid Tumors","FGFR Gene Amplification","FGFR Gene Alterations","FGFR3 Gene Alteration","FGFR3 Gene Mutation","Advanced Solid Tumors","FGFR4 Gene Mutation","FGFR4 Gene Fusions","FGF19 Gene Amplification","FGF19 Gene Overexpression","FGFR3 Gene Fusions","Locally Advanced Unresectable Hepatocellular Carcinoma",[162,163,164,165,166,167,168,169,170,171,172,173,174],"Hepatocellular Carcinoma","metastatic cancer","solid tumors","FGF19 gene amplifications","FGFR4 gene alterations","FGFR3 gene alterations","FGF19 gene alterations","FGFR4 gene mutations","FGFR4 gene fusions","FGFR3 gene mutations","FGFR3 gene fusions","FGF19 gene overexpression","locally advanced unresectable cancer","2026-07-27",{"date":177,"type":38},"2026-07-29",{"date":179,"type":38},"2025-04-24",{"date":181,"type":22},"2028-09",{"name":183,"class":111},"Tyra Biosciences, Inc",16,{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":202,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100532907","phase-1-phase-1-study-to-investigate-tcrts-kras-mutation-in-unresectable-advanced-andor-metastatic-solid-tumors-100532907","NCT06218914","Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Open-label, Phase 1, Multi-Center Master Protocol to Evaluate the Safety and Preliminary Anti-Tumor Activity of TCR-engineered T Cells Recognizing KRAS Mutations in Adult Subjects With Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor\n* Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C\\*08:02 positive, HLA-A\\*11:01 or HLA-A\\*11:02 positive in at least one allele\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Presence of at least 1 measurable lesion per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n\nKey Exclusion Criteria:\n\n* Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of stroke or transient ischemic attack within the 12 months prior to enrollment.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)\n* Female of childbearing potential who is lactating or breast feeding at the time of enrollment\n* Prior treatment with pan-KRAS or KRAS G12D targeting agents unless presence of KRAS G12D mutation is confirmed after the completion of treatment with pan-KRAS or KRAS G12D targeting agents.",{"count":193,"type":22},108,[25],"Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and\u002For Metastatic Solid Tumors.",[197,198,199,200,30,201],"Non-small Cell Lung Cancer","Colorectal Carcinoma","Pancreatic Ductal Adenocarcinoma","Endometrial Cancer","KRAS G12D",[203,204,201,205,206,207,208,209,199,210,211,212],"TCR-T cell therapy","KRAS","Autologous","PDAC","NSCLC","Colorectal Cancer","Solid tumors","HLA-C*08:02","HLA-A*11:01","HLA-A*11:02",{"date":214,"type":38},"2026-07-28",{"date":216,"type":38},"2024-03-22",{"date":218,"type":22},"2043-11-18",{"name":220,"class":111},"AstraZeneca",18,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":75},"100648247","phase-1-hmpl-a830-in-solid-tumors-100648247","NCT07718581","HMPL-A830 in Solid Tumors","A Phase I\u002FⅡa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors","Inclusion Criteria:\n\n1. Understood this study and are able to voluntarily sign the informed consent form (ICF);\n2. Male or Female, Age ≥ 18 years;\n3. Histological confirmed, unresectable, advanced or metastatic solid tumor\n4. Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1\n5. Life expectancy ≥ 12 weeks\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1\n\nExclusion Criteria:\n\n1. Use strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug\n2. Major surgery within 28 days prior to the first dose of study drug\n3. Active infection requiring systemic treatment\n4. History of inflammatory gastrointestinal diseases\n5. Known hypersensitivity to any component of HMPL-A830\n6. Pregnant (positive pregnancy test) or lactating;",{"count":230,"type":22},147,[25,86],"This is a first-in-human (FIH), multicenter, open-label, phase I\u002FⅡa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors\\*, who are refractory or progressed on\u002Fafter available standard treatment. The study will be conducted in 2 parts:\n\nDose Escalation (Part A, Phase I), approximately 57 participants will be enrolled.\n\nDose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.",[30],"2026-07-17",{"date":236,"type":38},"2026-07-22",{"date":238,"type":22},"2026-08-15",{"date":240,"type":22},"2028-11-26",{"name":242,"class":111},"Hutchmed",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},"100536504","phase-1-first-in-human-study-of-cx-2051-in-advanced-solid-tumors-100536504","NCT06265688","First In Human Study of CX-2051 in Advanced Solid Tumors","An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Measurable disease per RECIST v1.1\n* Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue\n* Additional inclusion criteria may apply\n\nExclusion Criteria:\n\n* Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated\n* Known active central nervous system (CNS) involvement by malignancy\n* Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1\n* Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload\n* Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1\n* Elevated baseline laboratory values\n* Serious concurrent illness\n* Pregnant or breast feeding\n* Additional exclusion criteria may apply",{"count":251,"type":22},160,[25],"The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 as a monotherapy and in combination with bevacizumab in adult participants with advanced solid tumors.",[30],"2026-07-14",{"date":257,"type":38},"2026-07-15",{"date":259,"type":38},"2024-04-02",{"date":261,"type":22},"2029-03-31",{"name":263,"class":111},"CytomX Therapeutics",8,{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":276,"conditions":277,"keywords":278,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":4},"100630448","phase-2-ivermectin-combined-with-immune-checkpoint-inhibition-in-cancer-iconic-100630448","NCT07487805","Ivermectin Combined With Immune Checkpoint Inhibition in Cancer (ICONIC)","Ivermectin Combined With Immune-Checkpoint Inhibition in Cancer (ICONIC)","ICONIC","Inclusion Criteria:\n\n* Histologically or clinically confirmed solid tumor malignancy for which the patient has been receiving an immune checkpoint inhibitor (ICI) as part of standard of care for ≥21 days prior to the first ivermectin dose, either alone or in combination with other systemic therapies. Both metastatic and (neo)adjuvant treatment settings are permitted.\n* Adults ≥ 18 years of age.\n* ECOG Performance Status of 0-2.\n* Subjects must be able to swallow oral medication.\n* Subjects must not have any known and active gastrointestinal disorders that impact absorption (e.g., inflammatory bowel disease, short bowel syndrome, severe diarrhea, prior major GI surgery \\[e.g., gastric bypass\\], or chronic vomiting) as determined by the investigator.\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.\n* Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.\n* Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 4 weeks following the last dose of study drug.\n\nExclusion Criteria:\n\n* Subjects who are currently taking, or have taken, ivermectin without a washout period prior to first treatment on study.\n\n  a. Subjects can become eligible for study participation if they do a 2-week wash-out period prior to first treatment on study.\n* Subjects who have received their first dose of ICI therapy \\\u003C21 days before the baseline visit.\n\n  a. Subjects can become eligible for study participation after ≥21 days have passed following Cycle 1 of ICI.\n* Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug.\n* Subjects who are confirmed to be pregnant or breastfeeding.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* Administration of all vaccines within 30 days prior to the first dose of trial treatment and while on treatment.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Rental function: Creatinine clearance ≤ 30 mL\u002Fmin\n* Hepatic function:\n\n  1. Total bilirubin \\> 1.5 x ULN unless patients with Gilbert Syndrome (total bilirubin \\> 3 x ULN)\n  2. Liver metastasis: AST\u002FALT \\> 5 x ULN\n* Concomitant use of Strong CYP3A4 inhibitor for 7 days or 5 half-lives, whichever is longer\n* Concomitant use of Strong CYP3A4 inducer for 14 days or 5 half-lives, whichever is longer\n* QTc \\> 480 msec",{"count":274,"type":22},80,[86],"Public awareness of ivermectin's purported anticancer properties has led to widespread off-label use. In a 2023 cross-sectional study in Loja, Ecuador, 19% of respondents reported using ivermectin as an adjunct to cancer treatment. However, clinical data remain virtually absent. To date, only one partially reported human study has investigated ivermectin in combination with anti-PD-1 therapy in patients with metastatic triple-negative breast cancer. Among the first nine treated patients, no treatment-related serious adverse events were observed, and the study remains ongoing.\n\nDespite this growing interest, ivermectin's off-label use carries risks. For instance, Gilene et al. described a case of severe neurotoxicity in a patient with metastatic osteosarcoma receiving regorafenib, likely due to a pharmacokinetic interaction through CYP3A49. Moreover, the potential impact of ivermectin on the gut microbiome-a key modulator of immune checkpoint inhibitor (ICI) immunotherapy success or failure efficacy-remains poorly understood. As antibiotic exposure has been linked to diminished immunotherapy outcomes, ivermectin's antibiotic properties raise legitimate concerns about possible microbiome disruption. However, variables such as ivermectin dose, the duration of exposure, and the type of immunotherapy are each variables that remain poorly studied.\n\nTaken together, these data underscore the urgency to prospectively evaluate ivermectin's immunologic effects in patients with cancer treated ICIs. Given ivermectin's wide availability, affordability, and public interest, rigorous clinical testing is crucial to determine whether it enhances-or potentially compromises-anticancer immunity while simultaneously assessing its safety to provide guidance for clinicians and patients.\n\nThis study will investigate the safety, pharmacodynamic effects, and potential for dose-responsive immune modulation of ivermectin given concurrently with immune checkpoint inhibitor therapy in adult subjects with solid tumors.",[30],[279,280,281,282,283],"immunotherapy","ivermectin","antitumor immune activation","microbiome","cancer","2026-07-13",{"date":257,"type":38},{"date":287,"type":22},"2026-09",{"date":289,"type":22},"2027-12",{"name":291,"class":45},"University of Florida",{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":46},"100579443","early-phase-1-proofprincip-intratu-tcells-singldoseimmuncheckpoininhib-gastro-esophage-adenocarcinoma-warid1a-mu-100579443","NCT06824363","ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w\u002FARID1a Mu","Proof of Principle Study Evaluating Single Dose Dual Immune Checkpoint Inhibitors to Increase Intra-tumoral T Cells in Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinomas With ARID1A Mutations: ESR-22-22082","Inclusion Criteria:\n\n* Non metastatic GEC including locally advanced unresectable\n* Treatment naïve\n* Histologically proven adenocarcinoma of the esophagus or the stomach with ARID1a mutation either by liquid biopsy (ctDNA) or tissue NGS\u002FWES\n* MSI-Stable or pMMR\n* Age ≥ 18 years\n* Body weight \\> 66 pounds\n* ECOG ≤ 2\n* Repeat biopsy feasible\n* No clinically significant autoimmune disease\n\nExclusion Criteria:\n\n* Patients with known metastatic disease\n* Prior systemic treatment for esophagus, GEJ, or the stomach adenocarcinoma\n* Patients with uncontrolled autoimmune disease per investigator discretion\n* Inability or refusal to undergo biopsy procedures to obtain tissue samples",{"count":300,"type":22},34,[302],"EARLY_PHASE1","This is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral T cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. These are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have ARID1A mutations.",[30,305,306,307],"Malignant Solid Tumor","Stomach Adenocarcinoma","Esophageal Adenocarcinoma","2026-07-02",{"date":310,"type":38},"2026-07-07",{"date":312,"type":38},"2026-05-25",{"date":314,"type":22},"2028-07",{"name":316,"class":45},"University of California, Irvine",{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":18,"minAge":324,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},"100434863","adapting-for-latinx-populations-an-intervention-that-involves-discussing-and-sharing-patients-health-related-values-100434863","NCT04942717","Adapting for Latinx Populations an Intervention That Involves Discussing and Sharing Patients' Health-Related Values","Communicating With Oncology Nurses About Values From the Outset (CONVO): An Innovative Primary Palliative Care Intervention in English and Espanol","Inclusion Criteria:\n\n* All participants will be adults (age ≥ 21) providing informed verbal consent. We seek a waiver of signed consent, which will allow use of virtual communication during the COVID-19 pandemic period.\n* Patients will be eligible as key informants in the translation\u002Ftranscreation process (Aim 1) if they are receiving medical oncology care for a solid tumor malignancy at RLC, SBH, or Jacobi and speak Spanish as their preferred language. In addition, English-speaking Latinx patients will be eligible to participate in interviews based on the back-translated (Spanish-to-English) version of the Guide\n\n  * We are focusing on patients with solid tumors rather than hematologic malignancies because 1) patients in the latter group may be receiving initial oncologic treatment in the hospital, whereas our study staff will be based at a distance from the hospital in the ambulatory clinics; 2) the trajectory, patient characteristics, and other aspects of hematologic malignancies tend to be different from solid tumor malignancies such that it would be more difficult to understand the overall impact of the intervention if patients with both types of malignancies w ere included.\n* Spanish-speaking family\u002Fother informal caregivers (collectively referred to as \"family\") who accompany participating patients to clinic will also be eligible to participate in interviews as part of the Aim 1 translation\u002Ftranscreation process. These will be individual interviews, conducted separately for patient and family participants.\n* Clinicians eligible for participation in the transcreation will be oncology physicians, nurses and other key clinical staff (e.g. social workers, advance practice providers, etc.) at RLC and other MSK sites who are Latinx and\u002For whose practice includes \\>20% Latinx patients.\n* Site leaders at SBH, Jacobi, and RLC with administrative responsibility for medical oncology will be eligible as key informants in transcreation of CONVO.\n* For the Aim 2 pilot trial, patients will be eligible if they are receiving systemic chemotherapy at SBH or Jacobi for a solid tumor; identify as Latinx; and speak English and\u002For Spanish. Family and\u002For informal caregivers who accompany the patient and speak English and\u002For Spanish will also be eligible (if the patient opts to include the family and\u002For informal caregiver in the CONVO discussion).\n* Nurses providing outpatient oncology care in chemotherapy areas at SBH or Jacobi will be eligible to participate in the pilot trial.\n\nExclusion Criteria:\n\n* Inability to understand consent procedure in either English or Spanish will be an exclusion. (The consenting professional will be bilingual \\[English\u002FSpanish\\] and able to explain and obtain consent in either language.)","21 Years",{"count":326,"type":22},234,[58],"The purpose of this study is to translate and tailor for Latinx participants a program called Communicating with Oncology Nurses about Values from the Outset (CONVO). In CONVO, routine cancer care for each participant includes a discussion between the nurse and participant about the participant's health-related values.",[61,30,330],"Solid Tumor, Unspecified, Adult",[332,333,61,334,66],"Spanish speaking","Latinx","20-539","2026-07-01",{"date":308,"type":38},{"date":338,"type":38},"2021-06-18",{"date":340,"type":22},"2027-06-18",{"name":66,"class":45},5,{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":366},"100512874","phase-1-ima402-t-cell-engaging-receptor-molecule-tcer-in-recurrent-andor-refractory-solid-tumors-100512874","NCT05958121","IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and\u002For Refractory Solid Tumors","A Phase I\u002FII First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) Targeting PRAME, as Monotherapy or in Combination With a Checkpoint Inhibitor in Patients With Recurrent and\u002For Refractory Solid Tumors","Inclusion Criteria:\n\n* Patients ≥ 18 years old\n* Patients must have a specific pathologically confirmed and documented advanced and\u002For metastatic solid tumor indication\n* Patients must have received or not be eligible for indicated standard-of-care treatments per cohort\n* Measurable disease according to RECIST 1.1\n* Confirmed HLA status\n* ECOG Performance Status of 0 to 1\n* Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status\n\nExclusion Criteria:\n\n* Other active malignancies that require treatment or that might interfere with the trial endpoints\n* The patient is pregnant or is breastfeeding\n* History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product\n* The patient has concurrent severe and\u002For uncontrolled medical disease. Any other health condition that would, in the investigator's or sponsor's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures\n* Patients with active brain metastases, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation",{"count":351,"type":22},400,[25,86],"The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and\u002For refractory solid tumors.\n\nPrimary objectives:\n\n* To determine the maximum tolerated doses and\u002For recommended doses for extensions for IMA402 as monotherapy and in combination with pembrolizumab (Phase Ia)\n* To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase I\u002FII)\n* To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)\n\nSecondary objectives:\n\n* To evaluate the initial anti-tumor activity of IMA402 as monotherapy and in combination (Phase I)\n* To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)\n* To describe the PK of IMA402 as monotherapy and in combination (Phase I\u002FII)",[355,356,30,357],"Refractory Cancer","Recurrent Cancer","Cancer","2026-06-29",{"date":335,"type":38},{"date":361,"type":38},"2023-08-09",{"date":363,"type":22},"2027-09",{"name":365,"class":111},"Immatics Biotechnologies GmbH",29,{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":386},"100551646","phase-1-first-in-human-study-of-cx-801-in-advanced-solid-tumors-100551646","NCT06462794","First In Human Study of CX-801 in Advanced Solid Tumors","An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors","Inclusion Criteria:\n\n* Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Measurable disease per RECIST v1.1\n* Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue\n* Adequate organ function\n* Additional inclusion criteria may apply\n\nExclusion Criteria:\n\n* Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated\n* Known active central nervous system (CNS) involvement by malignancy\n* Prior PD-1\u002F PD-(L)1 inhibitor treatment discontinued due to grade 3 or higher immune related adverse event\n* Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment\n* Investigational drug or device within 4 weeks prior to first dose of study treatment\n* Radiation within 2 weeks prior to first dose of study treatment\n* Serious concurrent illness\n* Pregnant or breast feeding\n* Additional exclusion criteria may apply",{"count":375,"type":22},121,[25],"The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.",[30],"2026-06-25",{"date":358,"type":38},{"date":382,"type":38},"2024-08-28",{"date":384,"type":22},"2029-06-30",{"name":263,"class":111},4,{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":407},"100379336","phase-1-a-study-of-bi-1206-in-combination-with-pembrolizumab-in-subjects-with-advanced-solid-tumors-100379336","NCT04219254","A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors","A Phase 1\u002F2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Is willing and able to provide written informed consent for the trial.\n* Is ≥18 years of age on day of signing informed consent.\n* Phase I only: Has a histologically confirmed advanced solid tumor. Subjects must have received at least 2 doses of an approved anti-PD-1\u002FL1 mAb, and have documented progression on or within 12 weeks from the last dose of anti-PD-1\u002FL1 mAb.\n* For patients with NSCLC (phase 2A SC cohorts):\n\nHave a histologically confirmed diagnosis of advanced or metastatic NSCLC and not have an EGFR sensitizing (activating) mutation or an ALK translocation.\n\nHave a PD-L1 positive (TPS≥50%) tumor as determined by IHC at a local laboratory.\n\nHave not received prior systemic immunotherapy or chemotherapy treatment for their advanced\u002Fmetastatic NSCLC.\n\nHave provided formalin-fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a lesion not previously irradiated to perform biomarker analysis.\n\n• For patients with uveal melanoma (phase 2A SC cohort): Have a histologically confirmed diagnosis of advanced or metastatic uveal melanoma\n\nHave a PD-L1 positive (TPS≥1%) tumor as determined by IHC at a local laboratory.\n\nHave not received prior systemic immunotherapy or chemotherapy treatment for their advanced\u002Fmetastatic uveal melanoma. Subjects who have received previous treatment with tebentafusp and\u002For liver directed therapy are allowed.\n\nHave provided formalin-fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a site not previously irradiated to perform biomarker analysis.\n\n* Phase I only: Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.\n* Has at least 1 measurable disease lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)\n* Phase IIa only: Is willing to provide an archival tumor tissue sample or newly obtained \\[core, incisional, OR excisional\\] biopsy of a tumor lesion not previously irradiated.\n* Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1206.\n* Has a life expectancy of ≥12 weeks.\n* Has an ECOG performance status of 0-1.\n* Has adequate organ function as confirmed by laboratory values listed in the main body of the protocol\n* Phase IIa only: Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrolment\n* Phase IIa only: Participants with history of HCV infection are eligible if HCV viral load is undetectable at Screening\n* Phase IIa only: Has adequate hematological and biochemical indices as listed in the main body of the protocol\n\nExclusion Criteria:\n\n* Needs doses of prednisolone \\>10 mg daily (or equipotent doses of other corticosteroids) while on the study, other than as premedication.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has known or suspected hypersensitivity to pembrolizumab or BI-1206 or any of their excipients.\n* Has cardiac or renal amyloid light-chain (AL) amyloidosis.\n* Has received radiotherapy within 2 weeks of the first dose of BI-1206.\n* Has not recovered from AEs to at least Grade 1 by CTCAE v5.0 (or higher) due to prior anticancer therapies• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n* Has an active, known or suspected autoimmune disease.\n* Is a female subject and has the ability to become pregnant (or already pregnant or lactating\u002Fbreastfeeding)\n* Is a male subject with partner(s) of childbearing potential (unless he agrees to use a barrier method of contraception during the study and for 12 months after completing treatment)\n* Has had major surgery from which the subject has not yet recovered Is at high medical risk because of non-malignant systemic disease, including severe active infections on treatment with antibiotics, antifungals, or antivirals\n* Has presence of chronic graft-versus-host disease.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Has a known history of HIV infection\n* Has a history of active tuberculosis (Bacillus tuberculosis)\n* Has received a live vaccine within 30 days before the first dose of study treatment\n* Has uncontrolled or significant cardiovascular disease as listed in the main body of the protocol\n* Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or lead to participation not being in the best interest of the subject, in the opinion of the treating Investigator.\n* Is participating or planning to participate in another interventional clinical study or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug\n* Has a known additional malignancy of another type, with the exception of adequately treated cone-biopsied carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) and basal or squamous cell carcinoma of the skin\n* Has a diagnosis of primary or acquired immunodeficiency disorder or has taken any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Is unable to attend the study site to receive the study treatment\n\nAdditional exclusion criteria are described in the protocol.",{"count":395,"type":22},197,[25,86],"Phase 1\u002F2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors",[30],"2026-06-22",{"date":379,"type":38},{"date":402,"type":38},"2020-06-29",{"date":404,"type":22},"2027-11",{"name":406,"class":111},"BioInvent International AB",26,{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":430,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":456},"100564176","phase-1-open-label-study-of-bbo-10203-in-subjects-with-advanced-solid-tumors-100564176","NCT06625775","Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)","Inclusion Criteria:\n\n* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive\u002FHER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)\n* Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)\n* Stable brain metastases\n* Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)\n* Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy\n* BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4\u002F6i\n* BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted\n* BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required\n\nExclusion Criteria:\n\n* Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR\u002FMSI-H tumors\n* Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1\u002FBRAF\u002FRET\u002FMET\u002FEGFR exon20 insertion\u002FNTRK\u002FHER2)\n* Patients with untreated and\u002For non-stable brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol",{"count":416,"type":22},392,[25],"First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.",[30,420,421,422,423,424,425,426,427,428,429],"Metastatic Breast Cancer","Advanced Breast Cancer","HER2 Mutation-Related Tumors","HER2-positive Metastatic Breast Cancer","KRAS Mutant Metastatic Colorectal Cancer","Metastatic Lung Cancer","Metastatic Colorectal Cancer","Advanced Lung Cancer","HR-positive, HER2-negative Advanced Breast Cancer","HER2-positive Advanced Breast Cancer",[431,432,433,434,435,436,437,438,439,440,207,441,442,443,444,445,446],"BREAKER-101","BridgeBio Oncology Therapeutics","BBOT","Phase1","Phase 1a\u002F1b","Trastuzumab","Breast","Colorectal","Non-Small Cell Lung Cancer","CRC","Metastatic Cancer","Advanced Cancer","HER2-positive","HR-positive","HR-positive, HER2-negative","HER2-negative","2026-06-18",{"date":449,"type":38},"2026-06-23",{"date":451,"type":38},"2024-10-29",{"date":453,"type":22},"2028-11",{"name":455,"class":111},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)",40,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":23,"phases":465,"briefSummary":466,"conditions":467,"keywords":479,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":46},"100644129","phase-1-imaging-study-of-89zrdfo-ys5-for-cancer-detection-100644129","NCT07664397","Imaging Study of [89Zr]DFO-YS5 for Cancer Detection","A Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detection of Cancer in Patients With Various Malignancies","Inclusion Criteria:\n\n1. Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm.\n2. At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)\u002FCT (scan imaging as documented in the medical record). Exception: For participants with localized bladder cancer (pre-cystectomy), lesions smaller than 1 centimeter (cm) are permitted, provided there is cystoscopic confirmation of a bladder mass.\n3. Clinically able to undergo PET-CT imaging or PET-MRI.\n4. Age ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1).\n6. Adequate organ function as defined below:\n\n   * Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).\n   * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)): ≤ 3 x ULN.\n   * Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)): ≤ 3 x ULN.\n   * Estimated creatinine clearance: ≥ 60 mL\u002Fmin, calculated using the Cockcroft-Gault equation.\n7. Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries). The result of the urine or serum pregnancy test must be negative in order to initiate the \\[89Zr\\]DFO-YS5 administration. If a urine pregnancy test is positive or equivocal, a confirmatory a serum pregnancy test is required. The individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5.\n8. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.\n9. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) or PET-MRI (e.g., implanted devices, metallic objects, or other implants). Participants must be able to undergo either PET-CT or PET-MRI.\n2. Individuals who are pregnant or breastfeeding\u002Fchest-feeding. Pregnant and breastfeeding\u002Fchest-feeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5. Females of childbearing potential must have a negative pregnancy test before administration of \\[89Zr\\]DFO-YS5, as outlined in inclusion criterion #7. Breastfeeding\u002Fchest-feeding should be discontinued before administration of \\[89Zr\\]DFO-YS5.\n3. Individuals who do not agree to follow the below contraception requirements:\n\n   Females of reproductive potential (defined below) must agree to use two forms of contraception, consisting of a barrier method (such as condoms) in combination with a secondary complementary method (such as hormonal, Intrauterine device (IUD), etc.), or strict abstinence, for the duration of study participation and for 1 month after administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n4. Hypersensitivity to \\[89Zr\\]DFO-YS5 or any of its excipients.\n5. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.",{"count":456,"type":22},[25],"This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\\[89Zr\\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.",[468,469,470,471,472,473,474,475,476,477,30,478],"Bladder Cancer","Nerve Sheath Tumor","Nerve Sheath Tumors","Solid Tumor Malignancies","Solid Tumor Cancer","Solid Tumor Neoplasms","Advanced Solid Tumor","Bladder Neoplasm","Nerve Sheath Neoplasms","Nerve Sheath Tumor, Nos","Solid Carcinoma",[480],"Imaging Study","2026-06-17",{"date":483,"type":38},"2026-06-24",{"date":485,"type":22},"2026-08-01",{"date":487,"type":22},"2029-09-30",{"name":489,"class":45},"Robert Flavell, MD, PhD",{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":501,"conditions":502,"keywords":518,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":541},"100520064","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-mesothelin-targeting-logic-gated-car-t-in-participants-with-solid-tumors-that-express-msln-and-have-lost-hla-a02-expression-100520064","NCT06051695","A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Autologous Logic-gated Tmod™ CAR T Products, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","EVEREST-2","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long term safety follow up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. MESO with pleural involvement extending into the peritoneum\n5. Cancer therapy within 3 weeks or 3 half lives of infusion\n6. Radiotherapy within 28 days of infusion\n7. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n8. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n9. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n10. Requires supplemental home oxygen\n11. Females of childbearing potential who are pregnant or breastfeeding\n12. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion",{"count":499,"type":22},474,[25,86],"The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\nPhase 1: What is the recommended dose that is safe for patients\n\nPhase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\nEnrollment and Apheresis in BASECAMP-1 (NCT04981119)\n\nPreconditioning Lymphodepletion (PCLD) Regimen\n\nTmod CAR T cells at the assigned dose",[30,208,207,503,504,505,506,507,508,440,509,510,357,511,512,513,514,515,516,517],"Non Small Cell Lung Cancer","NSCLC, Recurrent","Non-Small Cell Squamous Lung Cancer","Pancreas Cancer","Pancreatic Neoplasm","Colorectal Adenocarcinoma","Colon Cancer","Rectal Cancer","Ovarian Cancer","Ovarian Neoplasms","Mesothelioma","Mesothelioma, Malignant","Ovary Cancer","Lung Cancer","MESOM",[519,149,205,520,521,522,523,524,525,526,527,528,357,529,440,208,516,207,530,517,511,513,531],"CAR T Cell","T Cell","Mesothelin","MSLN","HLA-A2","Solid Tumors expressing MSLN","Pancreatic","Cell Therapy","Gene Therapy","blocker","PANC","OVCA","Logic-gate","2026-06-10",{"date":534,"type":38},"2026-06-12",{"date":536,"type":38},"2024-04-03",{"date":538,"type":22},"2029-06",{"name":540,"class":111},"A2 Biotherapeutics Inc.",12,{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":551,"briefSummary":552,"conditions":553,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":84},"100558720","phase-1-first-in-human-study-of-db-1419-for-advancedmetastatic-solid-tumors-100558720","NCT06554795","First-in-human Study of DB-1419 for Advanced\u002FMetastatic Solid Tumors","A Phase 1\u002F2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Adults aged ≥ 18 years at the time of voluntarily signing informed consent.\n2. Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available.\n3. At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria (Only applicable to backfill participants in phase 1a and participants in phase 1b\u002F2a). CRPC participants with bone-only disease may be eligible on a case-by-case basis after discussion with the Medical Monitor.\n4. Has a life expectancy of ≥ 3 months.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.\n6. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.\n7. Has adequate organ function within 7 days prior to the first dose of study treatment.\n8. Has adequate treatment washout period prior to the first dose of study treatment.\n9. Is willing to provide pre-existing resected tumor samples when available or undergo fresh tumor biopsy if feasible for the measurement of B7-H3 level and other biomarkers if no contraindication.\n\n   Note: there is no minimum B7-H3 expression level mandatory for entry into the study.\n10. Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.\n11. Male and female participants of reproductive\u002Fchildbearing potential must agree to avoid pregnancy during the study and for at least 4 months and 7 months after the last dose of study treatment, respectively.\n12. Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study treatment administration. Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study treatment administration.\n\nExclusion Criteria:\n\n1. Prior treatment with B7-H3 targeted therapy or prior treatment with ADC containing a topoisomerase I inhibitor payload.\n2. Has a medical history of symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] classes II-IV or serious cardiac arrhythmia requiring treatment.\n3. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.\n4. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \\> 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.\n5. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis which needs glucocorticoids and antibiotics) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.\n6. Has a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.\n7. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.\n8. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals within 2 weeks before first dose of study treatment.\n9. Know human immunodeficiency virus (HIV) infection.\n10. Has active viral hepatitis.\n11. Is a lactating mother, or pregnant as confirmed by pregnancy tests performed within 7 days prior to enrollment.\n12. Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with asymptomatic CNS metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed therapy, and are on stable or decreasing doses of corticosteroids equivalent to ≤10 mg\u002Fday prednisone are eligible for study entry.\n13. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v 5.0, Grade ≤ 1 or baseline.\n14. Has a prior history of immune-related adverse event that required permanent immune checkpoint inhibitor discontinuation per NCCN guidelines.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":550,"type":22},360,[25,86],"A Phase 1\u002F2a First-in-Human Study of DB-1419 in Advanced\u002FMetastatic Solid Tumors",[30],"2026-06-04",{"date":556,"type":38},"2026-06-05",{"date":558,"type":38},"2024-09-03",{"date":560,"type":22},"2027-02",{"name":562,"class":111},"DualityBio Inc.",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":23,"phases":572,"briefSummary":573,"conditions":574,"keywords":585,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":604},"100586569","phase-1-bbo-11818-in-adult-subjects-with-kras-mutant-cancer-100586569","NCT06917079","BBO-11818 in Adult Subjects With KRAS Mutant Cancer","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers","Inclusion Criteria:\n\n* Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation\n* Measurable disease by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Life expectancy \\>24 weeks\n* Adequate organ function\n\nExclusion Criteria:\n\n* Malignancy within the last 2 years as specified in the protocol\n* Untreated brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol.",{"count":571,"type":22},665,[25],"A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.",[439,207,575,576,577,578,579,580,201,581,582,583,584,30],"PDAC - Pancreatic Ductal Adenocarcinoma","CRC (Colorectal Cancer)","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","KRAS G12A","KRAS G12C","KRAS G12S","KRAS G12V","Metastatic Pancreatic Ductal Adenocarcinoma","Advanced Lung Carcinoma",[433,432,434,435,207,440,206,441,442,586,587,588,589,590,591,592,593,594,595],"Pembrolizumab","Cetuximab","Platinum Chemotherapy","Pemetrexed","KONQUER","KONQUER-101","mFOLFOX6","mFOLFIRINOX","Gemcitabine","Nab-paclitaxel","2026-05-29",{"date":598,"type":38},"2026-06-02",{"date":600,"type":38},"2025-03-31",{"date":602,"type":22},"2029-09",{"name":455,"class":111},17,{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":615,"phases":4,"briefSummary":616,"conditions":617,"keywords":624,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":630,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":634,"locationsCount":184},"100437810","solid-tumor-analysis-for-hla-loss-of-heterozygosity-loh-and-apheresis-for-car-t--cell-manufacturing-100437810","NCT04981119","Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing","An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing","BASECAMP-1","Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria\n\n1\\. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n\nPart 1: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n\nPart 2 : Key Inclusion Criteria\n\n1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n2. Participants are germline HLA-A\\*02 heterozygous confirmed by HLA typing.\n3. Primary tumor tissue showing LOH of HLA-A\\*02 by NGS testing.\n4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.\n\nPart 2: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n4. Participants who have received any cancer therapy on any investigational therapy for any indication, including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned apheresis or 3 half-lives, whichever is shorter.\n5. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with Intravenous (IV) antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of antibiotic course).\n6. Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.\n7. In the Investigator's judgement, any other condition or reason the subject would not complete the required study visits and procedures, and follow up visits, or comply with the study requirements for participation.",{"count":614,"type":22},200,"OBSERVATIONAL","Objective:\n\nTo collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.\n\nDesign:\n\nThis is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.",[30,208,503,618,440,207,506,513,511,512,619,514,620,357,621,622,623],"Pancreatic Cancer","Ovarian Carcinoma","Mesothelioma; Lung","Triple Negative Breast Cancer (TNBC)","Renal Cell Carcinoma (Kidney Cancer)","Head and Neck Squamous Cell Carcinoma HNSCC",[625,626,627,628,629],"CAR T Cell Therapy","Next Generation Sequencing","Leukapheresis","Apheresis","Immunotherapy",{"date":598,"type":38},{"date":632,"type":38},"2021-10-29",{"date":73,"type":22},{"name":540,"class":111},{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":23,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":669,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":46},"100348926","intravital-microscopy-in-human-solid-tumors-100348926","NCT03823144","Intravital Microscopy in Human Solid Tumors","Intravital Microscopy (IVM) in Human Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Eastern Cooperative Oncology Group (ECOG)Performance Status of ≤ 2\n* Measurable tumor by direct visualization requiring surgical resection in the operating room (OR)\n* Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, sarcoma, brain, or breast cancer that may involve the axillary lymph nodes cancers. Tumors may be primary or metastatic\n* Subject must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent\n* Subject must have a skin prick test pre-operatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given) to determine any sensitivity to fluorescein\n\nExclusion Criteria:\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations\n* Renal dysfunction as defined as a glomerular filtration rate (GFR) \\\u003C 45\n* Liver dysfunction as defined by Child-Pugh score \\> 5, or liver function test (LFT)'s 1.5 x above normal range\n* Any known allergy or prior reaction to fluorescein or a positive skin prick test to fluorescein\n* Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigators' opinion deems the patient unsuitable (e.g., abnormal electrocardiography \\[EKG\\], including T wave inversion, elevated T waves, prolonged QRS interval, or conduction blocks) or that requires further work-up (including cardiac echo or stress test)\n* Any condition that excludes surgical resection as the standard of care for the patient",{"count":643,"type":22},85,[58],"This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.",[30,647,648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663,664,665,666,667,668],"Clinical Stage IV Gastric Cancer AJCC v8","Malignant Solid Neoplasm","Metastatic Colorectal Carcinoma","Metastatic Gastric Carcinoma","Metastatic Primary Malignant Brain Neoplasm","Metastatic Sarcoma","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Resectable Colorectal Carcinoma","Resectable Liver and Intrahepatic Bile Duct Carcinoma","Resectable Pancreatic Carcinoma","Resectable Sarcoma","Stage IV Colorectal Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Malignant Brain Neoplasm","Metastatic Breast Carcinoma","Metastatic Liver Carcinoma","Metastatic Pancreatic Carcinoma","Resectable Brain Neoplasm","Resectable Breast Carcinoma","Resectable Gastric Carcinoma","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Pancreatic Cancer AJCC v8",{"date":598,"type":38},{"date":671,"type":38},"2019-02-28",{"date":673,"type":22},"2027-09-30",{"name":675,"class":45},"Mayo Clinic",{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":4,"eligibilityCriteria":682,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":683,"targetDuration":4,"studyType":23,"phases":685,"briefSummary":686,"conditions":687,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":688,"lastUpdatePostDateStruct":689,"startDateStruct":690,"completionDateStruct":692,"leadSponsor":694,"locationsCount":46},"100562041","phase-1-a-study-to-determine-the-effect-of-ct3001-in-patients-with-advanced-solid-tumors-100562041","NCT06598007","A Study to Determine the Effect of CT3001 in Patients With Advanced Solid Tumors","A Phase 1\u002F2 First-In-Human, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CT3001 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.\n* Aged ≥ 18 years (or adult age as per local regulations).\n* Histologically\u002Fcytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for whom no standard therapy exists. Note: In Phase 2b, only participants with advanced CRC who are eligible for re-engaging FOLFOX will be enrolled.\n* Has measurable disease per RECIST Version 1.1. that was not in a prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy.\n* Life expectancy ≥ 3 months, in the opinion of the PI or designee.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, liver, and kidney function as follows:\n\nBone marrow reserve:\n\n1. Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL without growth factor support in the 2 weeks prior to study entry.\n2. Hemoglobin ≥9.0 g\u002FdL without transfusion, growth factor support, or other supportive medication in the 2 weeks prior to study entry.\n3. Platelet count ≥ 75 × 10\\^9\u002FL without transfusion in 2 weeks prior to study entry.\n\nHepatic function:\n\n1. Serum TBIL \\\u003C 1.5 × ULN.\n2. AST and ALT \\\u003C 3 × ULN.\n\nRenal function:\n\nSerum creatinine clearance (CrCL) \\> 60 mL\u002Fmin, as per the Cockcroft-Gault Equation:\n\nCGGFR = \\[(140 - age in years) × weight in kg\\] \u002F (7.2 × serum creatinine in mg\u002FdL) (× 0.85 for females) (for urine protein \\\u003C 2+; if urine protein \\> 2+, 24-hour urinary protein quantity should be measured and must be \\\u003C 1.0 g).\n\n* Coagulation tests: international normalized ratio (INR) \\\u003C 1.5, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (Note: for those on oral anticoagulants, an INR in the range of 2 to 3 is acceptable).\n* Participants (both males and females) of childbearing potential should be willing to use a viable contraception method that is deemed effective by the PI or designee from Screening, during the study, and for at least 3 months following the last dose of IP. Postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential; postmenopausal status, if not known, is to be confirmed through testing of follicle-stimulating hormone (FSH) levels of ≥ 40 IU\u002FL. Male participants must be willing not to donate sperm until 3 months following the last IP administration.\n\nExclusion Criteria:\n\n* During Phase 1 Dose Escalation, receiving concurrent anticancer treatment (including chemotherapy, targeted drugs, radiotherapy \\[excluding the following small-area radiotherapy for bone metastasis\\], endocrine therapy, antitumor traditional Chinese Medicine), except during Phase 2b, Standard Care Chemotherapy (FOLFOX-based regimen) for advanced CRC patients is allowed.\n* Use of other IP within 5 half-lives of the product (if the IP is a small molecule) or anti-cancer investigational medical device within two weeks prior to the first administration of CT3001. Prior use of investigational monoclonal antibody IP can be permitted upon obtaining an approval from the Sponsor. Use of these investigational IP or devices are not permitted for the duration of treatment with CT3001.\n* Evidence of severe or uncontrolled systemic diseases, infection, or laboratory finding that in the view of the PI or designee makes it undesirable for the patient to participate in the trial.\n* Females who are pregnant or nursing, or any participant who is planning to become pregnant (self or partner) at any time during the study, including the Follow-up Period.\n* Has had major surgery or significant traumatic injury within 4 weeks of start of CT3001; participants have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or participant might require major surgery during the course of the study.\n* Has a prolonged QT interval corrected by Fredericia's formula (QTcF interval) of \\> 470 ms (determined by average of 3 readings on triplicate 12-lead ECG) or has a history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of long-QT syndrome) or current use of medications that prolong the QTcF interval.\n* Any psychiatric, psychological, familial or geographical condition that, in the judgment of the PI or designee, may interfere with the treatment and follow-up, affect compliance or place the participant at high risk of treatment-related complications will be excluded.\n* Blood donation or significant blood loss within 60 days prior to the first administration of CT3001.\n* History of severe allergic or anaphylactic reactions, or sensitivity to the CT3001 or its constituents.\n* Vaccination with a live vaccine within 4 weeks prior to the first administration of CT3001.\n* Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical study) within 5 half-lives of the product prior to the first administration of CT3001; these medications will not be permitted for the duration of treatment with CT3001.\n* Use of any medications with a narrow therapeutics index that are sensitive substrates of and metabolized mainly through CYP2C8 within 5-half-lives of the products prior to the first administration of CT3001; these medications will not be permitted for the duration of treatment with CT3001.\n* Use of any gastric acid reducing agents during the time period between 6 hours prior to and 2 hours after the administration of CT3001.\n* Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibodies (HIV-1\u002F-2) at Screening, unless the participant meets 1 of the following criteria:\n\n  1. Has chronic hepatitis B virus (HBV) infection or virologically suppressed (VS) HBV AND has been on suppressive antiviral therapy (unless it is a prohibited medication per exclusion criteria #12) for at least 4 weeks.\n  2. Has chronic HCV infection but has completed curative antiviral treatment (note: patients may be HCV antibody positive but must be HCV RNA negative to be eligible).\n\nPlease note: the eligibility of patients with HBV or HCV infection should be considered on a case-by-case basis by the PI in consultation with the independent Medical Monitor.\n\n* Anything that the PI considers would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.",{"count":684,"type":22},78,[25,86],"This is an FIH, multicenter, open-label, dose escalation and dose expansion\u002Fdose optimization study of CT3001, which will be conducted in 2 phases: Phase 1 and Phase 2b. Phase 1 will be a standard 3+3 dose escalation and dose finding study in patients with advanced solid tumors for whom there is no available therapy (or patients are not candidates for such therapy) for the assessment of DLTs at up to 7 dose levels of CT3001. Phase 2b is a dose finding\u002Fdose optimization study of CT3001 in combination with SOC chemotherapy (FOLFOX) to evaluate the safety and preliminary efficacy of CT3001 in patients with advanced CRC who are eligible for re-engaging FOLFOX-based chemotherapy.",[30,208,199],"2026-05-27",{"date":596,"type":38},{"date":691,"type":38},"2024-09-20",{"date":693,"type":22},"2027-06-30",{"name":695,"class":111},"Crossignal Therapeutics, Inc.",{"id":697,"slug":698,"hasResults":12,"nctId":699,"briefTitle":700,"officialTitle":701,"acronym":702,"eligibilityCriteria":703,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":704,"targetDuration":4,"studyType":23,"phases":706,"briefSummary":707,"conditions":708,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":709,"lastUpdatePostDateStruct":710,"startDateStruct":712,"completionDateStruct":714,"leadSponsor":716,"locationsCount":264},"100591231","phase-1-a-study-of-attr-01-in-participants-with-select-epithelial-solid-tumours-100591231","NCT06977737","A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours","A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants With Select Epithelial Solid Tumours Under Multiple Sub-protocols","ATTEST","Inclusion Criteria:\n\n* Consenting male and female adults (18 years of age) with select solid epithelial tumour indications known to have high frequency (75 percent) of αvβ6 integrin receptor expression as detailed in the applicable SP.\n* Received and failed\u002Fintolerant of Standard of Care (SoC) therapy where eligible (not including neoadjuvant).\n* Tumour lesion (not previously irradiated), suitable for safe pre- and post-treatment biopsies.\n* Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n* Minimum life expectancy anticipated to be greater than three months\n* Willing to undertake appropriate measures of hygiene to prevent any spread of virus and protection of vulnerable individuals.\n* Adequate organ function.\n* Compliant with requirements for prior treatment washout and contraceptive measures applicable to genetically modified organisms (GMOs) and cancer therapies\n* Prior immune checkpoint antibody therapies as single agents or in combination with other anti-cancer agents is permissible.\n\nExclusion Criteria:\n\n* Significant degree of fibrotic disease, including autoimmune diseases (e.g. systemic lupus, rheumatoid arthritis) or idiopathic and occupation-related pulmonary fibrosis.\n* Known prior history of intolerance to anti-programmed cell death protein 1 (PD-1) and\u002For anti-PD-L1 immunotherapy due to toxicity.\n* Has any of the comorbid conditions listed in the detailed protocol exclusion criteria.",{"count":705,"type":22},72,[25,86],"ATTR-01 is the experimental drug being studied in the ATTEST clinical trial. The drug is made from a common cold virus that has been changed to only infect and multiply in cancer cells. This virus delivers an immune therapy drug into the cancer that is intended to promote a participant's own immune system to attack the cancer. The first part of this trial (sub-protocol A) is a phase 1 trial including dose escalation and expansion at one or more doses. It is the first time that ATTR-01 will be given to humans. If an optimal dose is identified, additional sub-protocols will be added by to further elicit whether ATTR-01 may successfully treat cancer. Expanded access is not available.",[30],"2026-05-21",{"date":711,"type":38},"2026-05-22",{"date":713,"type":38},"2025-03-21",{"date":715,"type":22},"2034-12-31",{"name":717,"class":111},"Accession Therapeutics Limited",{"id":719,"slug":720,"hasResults":12,"nctId":721,"briefTitle":722,"officialTitle":723,"acronym":724,"eligibilityCriteria":725,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":726,"targetDuration":4,"studyType":23,"phases":728,"briefSummary":729,"conditions":730,"keywords":731,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":738,"lastUpdatePostDateStruct":739,"startDateStruct":741,"completionDateStruct":743,"leadSponsor":745,"locationsCount":747},"100338413","phase-1-actengine-ima203ima203cd8-as-monotherapy-or-in-combination-with-nivolumab-in-recurrent-andor-refractory-solid-tumors-100338413","NCT03686124","ACTengine® IMA203\u002FIMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and\u002For Refractory Solid Tumors","Phase 1\u002F2 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer\u002FGermline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and\u002For Refractory Solid Tumors","ACTengine","Inclusion Criteria:\n\n* Patients must have recurrent\u002Fprogressing and\u002For refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* HLA-A\\*02:01 positive\n* For patients with ovarian\u002Ffallopian tube cancer only: Patients must have confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.\n* For patients with endometrial carcinoma only: Patients must have a histologically confirmed diagnosis of recurrent or persistent endometrial carcinoma.\n* Measurable disease according to RECIST 1.1\n* Adequate selected organ function per protocol\n* Patient's tumor must express tumor antigen by \"IMADetect® RT-qPCR. Retrospective testing will be required for patients that qualify.\n* Life expectancy more than 5 months\n* Female patient of childbearing potential must use adequate contraception prior to study entry until 12 months after the infusion of IMA203\u002FIMA203CD8\n* Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203\u002FIMA203CD8\n* The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to lymphodepletion.\n\nExclusion Criteria:\n\n* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years\n* Pregnant or breastfeeding\n* Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.\n* History of cardiac conditions as per protocol\n* Prior stem cell transplantation or solid organ transplantation\n* Concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study\n* History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician\n* Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.\n* Patients with LDH greater than 2.0-fold ULN.\n* Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and\u002For IMA203\u002FIMA203CD8 treatment\n* Patients with active brain metastases\n* Concurrent treatment in another clinical trial.\n* For nivolumab treatment, patients must not have a history of severe immune-related toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1\u002FPD-L1 inhibitor therapy (e.g., atezolizumab, pembrolizumab or nivolumab etc.).\n\nOther protocol defined inclusion\u002Fexclusion criteria could apply",{"count":727,"type":22},375,[25,86],"The study's purpose is to establish the safety and tolerability of IMA203\u002FIMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).",[355,356,30,357],[732,279,733,734,619,735,736,737],"T-cell therapy","Melanoma (Skin)","Melanoma, Uveal","Uterine Carcinoma","Uterine Carcinosarcoma","Immatics","2026-05-12",{"date":740,"type":38},"2026-05-13",{"date":742,"type":38},"2019-05-14",{"date":744,"type":22},"2032-06",{"name":746,"class":111},"Immatics US, Inc.",21,{"id":749,"slug":750,"hasResults":12,"nctId":751,"briefTitle":752,"officialTitle":753,"acronym":754,"eligibilityCriteria":755,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":756,"targetDuration":4,"studyType":23,"phases":758,"briefSummary":759,"conditions":760,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":762,"lastUpdatePostDateStruct":763,"startDateStruct":764,"completionDateStruct":766,"leadSponsor":768,"locationsCount":46},"100442041","phase-1-coast-therapy-in-advanced-solid-tumors-and-prostate-cancer-100442041","NCT05036226","COAST Therapy in Advanced Solid Tumors and Prostate Cancer","Combination of Autophagy Selective Therapeutics (COAST) in Advanced Solid Tumors or Relapsed Prostate Cancer, A Phase I\u002FII Trial","COAST","Inclusion Criteria:\n\n1. Patient must have advanced solid tumor cancer of any type (Phase I) or advanced prostate cancer (Phase II). Prostate cancer patients must have a PSA of at least 0.1 ng\u002FmL.\n2. Tissue diagnosis documented by pathology report, or clinic note attesting to same.\n3. Measurable \u002F evaluable tumor by RECIST, quantitative blood biomarker, or radionuclide imaging\n4. Voluntary, signed and dated, Institutional Review Board (IRB) approved consent form in accordance with regulatory and institutional guidelines.\n5. Documented progression of disease during treatment with one or more standard systemic regimens. Single or multiple regimens of chemotherapy, hormone suppression therapy, radiation therapy, surgery, immunotherapy, or adoptive cell therapy are allowed.\n6. 18 years of age or older.\n7. ECOG performance status of 0-2.\n8. Bilirubin ≤ 1.5 times upper limit of normal (ULN) and AST \u002F ALT ≤ 3 times ULN. Subjects with Gilbert's syndrome may be included if the total bilirubin is \\\u003C 3 times ULN and the direct bilirubin is within normal limits.\n9. Serum creatinine ≤ 1.5 times ULN.\n10. Absolute neutrophil count (ANC) ≥ 1,000 cells \u002F mm3\n11. Platelet count ≥ 75,000 cells \u002F mm3\n12. Hemoglobin ≥ 9 g\u002F dL.\n13. Fasting glucose ≤ 160 mg\u002FdL or non-fasting glucose ≤ 200 mg\u002FdL.\n14. Urinalysis with no clinically significant abnormalities.\n15. Adequately controlled blood pressure as determined by the treating investigator.\n16. Subjects with the potential to produce children must agree to effective contraceptive method use during study participation.\n17. Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks prior to study entry.\n18. Patients being considered for a dose level containing nelfinavir mesylate must discontinue any statin use within 48 hours of beginning study treatment.\n\nExclusion Criteria:\n\n1. New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or history of ischemia on ECG.\n2. Underlying psychiatric disorder requiring hospitalization within the last two years.\n3. Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.\n4. Active, uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.\n5. Treatment with local or systemic radiation therapy, surgery, or investigational therapy within 28 days prior to registration.\n6. Unwillingness or inability to comply with procedures required in this protocol.\n7. Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator.\n8. Patients who are receiving, coumadin, apixaban, argatroban or rivaroxaban.\n9. Patients who are currently participating in any other clinical trial of an investigational product.\n10. Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator.\n11. Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.",{"count":757,"type":22},76,[25,86],"The purpose of this Phase I\u002FII study is to determine the safety and effectiveness of up to 5 study drugs used together for the treatment of solid tumor cancers. The drugs are hydroxychloroquine, metformin, sirolimus, dasatinib and nelfinavir and are given orally.",[761,30],"Prostate Cancer Recurrent","2026-05-11",{"date":740,"type":38},{"date":765,"type":38},"2022-03-03",{"date":767,"type":22},"2028-05-21",{"name":769,"class":45},"Medical University of South Carolina"]