[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07136779":3,"trial-entities:NCT07136779":185,"trial-summary:NCT07136779":189},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":47,"sex":86,"minimum_age":87,"maximum_age":15,"healthy_volunteers":88,"eligibility_criteria":89,"std_ages":107,"locations":110,"central_contacts":177,"overall_officials":182,"references":183,"see_also_links":184},"NCT07136779","VBC101-01-01","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","RECRUITING","2028-07-01","2026-08","2026-09-03","2025-09-23","VelaVigo Bio Inc","INDUSTRY",null,"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.","Protocol Version：V1.3 Version Date：2026-04-20",[19],"Participants With Advanced Solid Tumor Malignancies",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},310,"ESTIMATED",[30],{"type":31,"name":32,"description":32,"armGroupLabels":33},"DRUG","VBC101",[34],"Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion）",[36,40,44],{"measure":37,"description":38,"timeFrame":39},"Incidence of dose-limiting toxicities (DLT) as defined in the protocol","Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol","(DLT)From time of first dose of VBC101 to end of DLT period (approximately 21 days)",{"measure":41,"description":42,"timeFrame":43},"Incidence of Serious Adverse Events","Number of patients with serious adverse events by system organ class and preferred term","From time of Informed Consent to 30 days post last dose of VBC101",{"measure":45,"description":46,"timeFrame":43},"Incidence of Adverse Events(AEs)","Number of patients with adverse events by system organ class and preferred term",[48,52,55,59,63,67,71,74,77,80,83],{"measure":49,"description":50,"timeFrame":51},"Objective Response Rate (ORR)","The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)","From date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)",{"measure":53,"description":54,"timeFrame":51},"Duration of Response (DoR)","The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression",{"measure":56,"description":57,"timeFrame":58},"Disease Control Rate (DCR) at 12 weeks","The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1) for \\>=11 weeks from first dose","From date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks)",{"measure":60,"description":61,"timeFrame":62},"Progression free Survival (PFS)","The time from first dose until RECIST 1.1 defined disease progression or death due to any cause","From date of first dose of VBC101 up until date of progression or death due to any cause (approximately 2 years)",{"measure":64,"description":65,"timeFrame":66},"Overall Survival (OS)","The time from the date of the first dose of study treatment until death due to any cause.","From date of first dose of VBC101 up until the date of death due to any cause (approximately 2 years)",{"measure":68,"description":69,"timeFrame":70},"Pharmacokinetics of VBC101: Plasma PK concentrations","Measurement of plasma concentrations of VBC101, total antibody and total unconjugated warhead","From date of first dose of VBC101 up until 30 days post last dose",{"measure":72,"description":73,"timeFrame":70},"Pharmacokinetics of VBC101: Area under the concentration time curve (AUC)","Measurement of PK parameters: Area under the concentration time curve (AUC)",{"measure":75,"description":76,"timeFrame":70},"Pharmacokinetics of VBC101: Maximum plasma concentration of the study drug (C-max)","Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)",{"measure":78,"description":79,"timeFrame":70},"Pharmacokinetics of VBC101: Time to maximum plasma concentration of the study drug (T-max)","Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)",{"measure":81,"description":82,"timeFrame":70},"Pharmacokinetics of VBC101: Half-life","Measurement of PK parameters: Terminal elimination half-life (t 1\u002F2)",{"measure":84,"description":85,"timeFrame":70},"Immunogenicity of VBC101: Anti-Drug Antibodies (ADA)","Evaluating the number and percentage of patients who develop Anti-drug antibody (ADA) during treatment","ALL","18 Years",false,{"inclusion":90,"exclusion":101,"raw_text":106},[91,92,93,94,95,96,97,98,99,100],"1\\. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.","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","3\\. At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria","4\\. Male or female adults (defined as ≥ 18 years of age)","5\\. ECOG performance status 0-1","6\\. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.","7\\. Life expectancy greater than 12 weeks","8\\. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.","9\\. Adequate organ and bone marrow function","10\\. Participants must meet the minimum washout period requirements before the first dose of investigational drug",[102,103,104,105],"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.","3\\. Prior treatment with an ADC targeting EGFR and\u002For cMet (including VBC101)","4\\. Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101).","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.","Inclusion Criteria:\n\nA participant must meet all of the following inclusion criteria to be eligible to participate in this trial:\n\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.",[108,109],"ADULT","OLDER_ADULT",[111,126,139,151,164],{"facility":112,"status":8,"city":113,"state":114,"zip":115,"country":116,"contacts":117,"geoPoint":123},"Start Midwest","Grand Rapids","Michigan","49546","United States",[118],{"name":119,"role":120,"phone":121,"email":122},"Nehal Lakhani","CONTACT","16169545554","nehal.lakhani@startresearch.com",{"lat":124,"lon":125},42.96336,-85.66809,{"facility":127,"status":8,"city":128,"state":129,"zip":130,"country":116,"contacts":131,"geoPoint":136},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",[132],{"name":133,"role":120,"phone":134,"email":135},"David S. Hong","713-563-5844","dshong@mdanderson.org",{"lat":137,"lon":138},29.76328,-95.36327,{"facility":140,"status":8,"city":141,"state":129,"zip":142,"country":116,"contacts":143,"geoPoint":148},"NEXT Oncology","San Antonio","78229",[144],{"name":145,"role":120,"phone":146,"email":147},"David Sommerhalder, MD","+1 2105809500","dsommerhalder@nextoncology.com",{"lat":149,"lon":150},29.42412,-98.49363,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":116,"contacts":156,"geoPoint":161},"START Mountain Region, LLC.","West Valley City","Utah","84119",[157],{"name":158,"role":120,"phone":159,"email":160},"William McKean","801-907-4750","william.mckean@startresearch.com",{"lat":162,"lon":163},40.69161,-112.00105,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":116,"contacts":169,"geoPoint":174},"NEXT Virginia","Fairfax","Virginia","22031",[170],{"name":171,"role":120,"phone":172,"email":173},"Alexander Spira","703-783-4510","aspira@nextoncology.com",{"lat":175,"lon":176},38.84622,-77.30637,[178],{"name":179,"role":120,"phone":180,"email":181},"Chen Li","+86 13681943496","chen.li@velavigo.com",[],[],[],{"nct_id":4,"conditions":186,"biomarkers":188},[187],"Solid Neoplasm",[],{"nct_id":4,"found":190,"summary":191,"prompt_version":201},true,{"design":192,"status":193,"heading":194,"summary":195,"follow_up":196,"word_count":197,"commitments":198,"compensation":199,"drugs_mentioned":200},"This is a multi-center, open-label (everyone knows what treatment is being given), multiple-dose study with two parts, Phase 1 and Phase 2a. It plans to enroll up to 310 participants.","completed","First-in-Human Trial of VBC101 for Advanced Solid Tumor Malignancies","This study is a first-in-human trial testing a drug called VBC101 in people with advanced solid tumor malignancies (cancers that have spread). The main goals are to find a safe dose of VBC101 and to see how well it is tolerated. Researchers will be looking for any serious side effects or other problems that might limit the dose. You may be able to join if you are 18 years or older and have an advanced solid tumor. The study is currently unclear on its recruitment status and plans to enroll up to 310 participants.","You would be followed for serious side effects from the time you agree to participate until 30 days after your last dose of VBC101.",94,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]