[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"VelaVigo Bio Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,63],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100053941","phase-1-first-in-human-trial-of-vbc108-in-participants-with-advanced-malignant-solid-tumors-100053941",false,"NCT07700160","First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors","Phase 1\u002F2a Open-label Clinical Trial Evaluating VBC108, a CLDN18.2 and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.\n2. Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor .\n3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.\n4. Male or female adults (defined as ≥ 18 years of age).\n5. ECOG performance status 0-1.\n6. Life expectancy greater than 12 weeks.\n7. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.\n8. Adequate organ and bone marrow function.\n9. Participants must meet the minimum washout period requirements before the first dose of investigational drug.\n\nExclusion Criteria:\n\n1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.\n2. Known or suspected brain metastases, or spinal cord compression.\n3. Prior treatment with an ADC targeting CLDN18.2x CDH17 bispecific ADC.\n4. Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.\n5. Prior treatment with CLDN18.2 targeting CAR-T.","ALL","18 Years",{"count":19,"type":20},230,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a multicenter, open-label, multiple-dose, FIH Phase 1\u002F2a trial. The Phase 1 portion uses Bayesian optimal interval (BOIN) design to escalate and determine the MTD and\u002For RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC108.",[27],"Advanced Solid Tumors","NOT_YET_RECRUITING","2026-07-07",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":31,"type":20},{"date":35,"type":20},"2029-09-17",{"name":37,"class":38},"VelaVigo Bio Inc","INDUSTRY",12,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100615987","phase-1-clinical-trial-of-vbc103-in-patients-with-advanced-malignant-solid-tumors-100615987","NCT07299747","Clinical Trial of VBC103 in Patients With Advanced Malignant Solid Tumors","A Phase I\u002FIIa Clinical Study Evaluating the Bispecific Antibody-Drug Conjugate VBC103 Targeting Nectin-4 and TROP2 in Subjects With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* 1.The subject or their legal representative is willing and able to sign a written ICF before initiating any study procedures.\n* 2.Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor that has recurred or progressed during or after standard systemic therapy, or is intolerant to standard therapy, or lacks standard treatment options (applicable only to Phase I and Phase IIa Cohort 5).\n* 3.At least one measurable lesion as assessed by the investigator per RECIST v1.1.\n* 4.Adult male or female (defined as ≥18 years of age)\n* 5.ECOG performance status score of 0-1.\n* 6.LVEF ≥50% as measured by ECHO or MUGA within 28 days prior to enrollment.\n* 7.Life expectancy exceeding 12 weeks.\n* 8.Availability of archived tumor tissue samples or willingness to undergo biopsy sampling.\n\nExclusion Criteria:\n\n* 1.Any unresolved ≥Grade 2 toxicity from prior anticancer therapy.\n* 2.Known active keratitis or corneal ulcer.\n* 3.History of interstitial lung disease (e.g., non-infectious interstitial pneumonia, pneumonitis,pulmonary fibrosis, or severe radiation pneumonitis), current interstitial lung disease, or suspected interstitial lung disease based on imaging during the screening period.\n* 4.History of underlying pulmonary diseases, including but not limited to pulmonary embolism within 3 months prior to the start of investigational product, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, and other clinically significant pulmonary impairment or requiring supplemental oxygen, as well as any autoimmune, connective tissue, or inflammatory disease involving the lungs (such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.) and\u002For prior pneumonectomy (complete resection).",{"count":48,"type":20},255,[23,24],"This study is a multicenter, open-label, multi-dose, first-in-human (FIH) Phase I\u002FIIa study to determine the safety and tolerability of VBC103, as well as the maximum tolerated dose (MTD) and\u002For recommended Phase II dose (RP2D), PK and further evaluate its efficacy.",[52],"Participants With Advanced Solid Tumor Malignancies","RECRUITING","2026-04-17",{"date":56,"type":32},"2026-04-22",{"date":58,"type":32},"2025-12-04",{"date":60,"type":20},"2028-12-01",{"name":37,"class":38},1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100603458","phase-1-first-in-human-trial-of-vbc101-in-participants-with-advanced-solid-tumor-malignancies-100603458","NCT07136779","First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies","PHASE 1\u002F2A OPEN-LABEL CLINICAL TRIAL EVALUATING VBC101, AN EGFR AND CMET TARGETED BI-SPECIFIC ANTIBODY DRUG CONJUGATE, IN PARTICIPANTS WITH ADVANCED SOLID TUMOR MALIGNANCIES","Inclusion Criteria:\n\n* A participant must meet all of the following inclusion criteria to be eligible to participate in this trial:\n* 1\\. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.\n* 2\\. Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or for which no standard treatment is available\n* 3\\. At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria\n* 4\\. Male or female adults (defined as ≥ 18 years of age)\n* 5\\. ECOG performance status 0-1\n* 6\\. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.\n* 7\\. Life expectancy greater than 12 weeks\n* 8\\. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.\n* 9\\. Adequate organ and bone marrow function\n* 10\\. Participants must meet the minimum washout period requirements before the first dose of investigational drug\n\nExclusion Criteria:\n\n1\\. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment, except for alopecia, neuropathy, or skin pigmentation changes. Participants with chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the study investigator and the Sponsor's Medical Monitor.\n\n* 2\\. Known or suspected brain metastases, or spinal cord compression, unless the condition has been treated, asymptomatic, and has been stable without requiring escalating doses of corticosteroids (equivalent to ≤10 mg\u002Fday prednisone) or anti-convulsant medications for at least four weeks prior for the first dose of investigational drug.\n* 3\\. Prior treatment with an ADC targeting EGFR and\u002For cMet (including VBC101)\n* 4\\. Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101).\n* 5\\. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.",{"count":71,"type":20},310,[23,24],"This is a multicenter, open-label, multiple-dose, FIH Phase 1\u002F2a trial. The Phase 1 portion adopts an accelerated titration for the first dose level, followed by BOIN design to identify the MTD and\u002For RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC101.",[52],{"date":56,"type":32},{"date":77,"type":32},"2025-09-23",{"date":79,"type":20},"2028-07-01",{"name":37,"class":38},5,""]