[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cdh17-positive-advanced-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cdh17-positive-advanced-solid-tumors":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":41,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":4},"100633678","phase-1-phase-12-study-of-bhb810-in-advanced-gastric-and-gej-adenocarcinoma-100633678",false,"NCT07529808","Phase 1\u002F2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma","Phase 1\u002F2, Open-Label, Multicenter, Dose Escalation and Expansion Study of BHB810 in Participants With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.\n* Histologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on, was nonresponsive to, or for which no standard or available curative therapy exists.\n\n  * Participants in Phase 1 Backfill Cohorts \\& Phase 2 must be CDH17-positive by central testing.\n  * Other gastrointestinal (GI) tumor types may be enrolled in Backfill Cohorts and Phase 2.\n* At least 1 measurable target lesion at baseline per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)\n* Provision of FFPE archival tumor tissue. Additional fresh biopsies at screening are required in Phase 1 Backfill Cohorts and Phase 2.\n* Adequate organ and marrow function as defined in the protocol\n\nExclusion Criteria:\n\n* Prior cancer treatment as follows, relative to the first planned dose of trial intervention:\n\n  * Chemotherapy or targeted therapy withing 4 weeks or 5-halflives (whichever is shorter)\n  * Monoclonal antibody-based therapy (including ADCs) within 4 weeks\n  * Immune checkpoint inhibitors within 4 weeks\n  * Wide-field radiation therapy (\\>30% marrow-bearing bones) within 4 weeks or \\\u003C 2 weeks of focal palliative radiation to nontarget lesions\n* Prior treatment with a CDH17-directed therapy or an ADC with an auristatin (MMAE or MMAF)\n* Known hypersensitivity or allergic reaction to BHB810 or it's excipients\n* Left ventricular ejection fraction \\\u003C50% or history of congestive heart failure Class III\u002FIV\n* QTc interval \\> 470 msec, history of risk factors for Torsade de Pointes, or taking a medication known to prolong QT\u002FQTc\n* Pregnant or breastfeeding females, or if you or your partner are planning to become pregnant\n* Known or suspected brain metastases, leptomeningeal disease, or spinal cord compression. Participants with stable, treated brain metastases may be enrolled.\n* Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate within 2 weeks of first dose of trial intervention\n* Any condition that may compromise participant safety, compliance, or interfere with the evaluation of the study drug.","ALL","18 Years",{"count":19,"type":20},164,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study is looking at how safe BHB810 is in adults with gastric and gastroesophageal adenocarcinoma (GEJ). The purpose of this study is also to look at: how well the study drug works, how the study drug moves into, through, and out of the body, and how your body reacts to the study drug. Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Gastric Cancer","Gastric Adenocarcinoma","Gastric (Stomach) Cancer","Gastroesophageal Adenocarcinoma","Gastroesophageal Cancer (GC)","Gastroesophageal Junction (GEJ) Adenocarcinoma","Gastroesophageal Junction (GEJ) Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Adenocarcinoma","Gastrointestinal Cancers","Colorectal (Colon or Rectal) Cancer","Pancreatic Cancer","CDH17-positive Advanced Solid Tumors","Advanced Gastric Cancer",[42,43,44],"Antibody Drug Conjugate (ADC)","Monomethyl Auristatin E (MMAE)","CDH17 protein","NOT_YET_RECRUITING","2026-05-05",{"date":48,"type":49},"2026-05-08","ACTUAL",{"date":51,"type":20},"2026-06",{"date":53,"type":20},"2028-12",{"name":55,"class":56},"BigHat Biosciences, Inc.","INDUSTRY",{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100579140","early-phase-1-safety-and-preliminary-efficacy-of-anti-cdh17-car-t-cell-therapy-in-patients-with-cdh17-positive-advanced-solid-tumors-100579140","NCT06820424","Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of CDH17 CAR-T in Patients with CDH17-positive Advanced Solid Tumors","Inclusion Criteria:\n\n1. The patient understands and voluntarily signs the informed consent form, and is expected to complete the follow-up examination and treatment of the study procedures;\n2. Age 18-75 years old, gender unlimited;\n3. Tumor patients who have positive expression of CDH17 target in tumor tissues measured by immunohistochemistry (IHC) in a laboratory approved by the partner, and have no standard therapy or are ineffective or not suitable for standard treatment;\n4. Have at least one extracranial measurable lesion according to RECIST 1.1 criteria;\n5. Estimated survival ≥ 12 weeks;\n6. Baseline ECOG (Eastern Cooperative Oncology Group) score ≤ 1 point;\n7. The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade \\\u003C 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);\n8. Venous access could be established; without contraindications of apheresis.\n\nExclusion Criteria:\n\n1. Patients with prior or current other malignancies;\n2. Presence of brain metastases and clinically significant central nervous system disease;\n3. Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;\n4. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution\n5. Those who have a positive sputum smear and T-cell test for tuberculosis infection;\n6. Patients with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function, both past and present;\n7. Patients have a severe allergic history;\n8. Patients with severe heart disease or uncontrollable refractory hypertension;\n9. Patients with severe liver and kidney dysfunction or consciousness disorders;\n10. Active autoimmune or inflammatory diseases of the nervous system;\n11. Uncontrolled infections that need antibiotics treatment;\n12. Live attenuated vaccine within 4 weeks before screening;\n13. Alcoholics or persons with a history of drug abuse;\n14. Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;\n15. Any unsuitable to participate in this trial judged by the investigator.","75 Years",{"count":66,"type":20},30,[68],"EARLY_PHASE1","This is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors.",[39],[72],"CDH17 CAR-T","RECRUITING","2025-02-06",{"date":76,"type":49},"2025-02-11",{"date":78,"type":20},"2025-03",{"date":80,"type":20},"2028-06",{"name":82,"class":83},"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China","OTHER",1]