PHASE 1/2A OPEN-LABEL CLINICAL TRIAL EVALUATING VBC101, AN EGFR AND CMET TARGETED BI-SPECIFIC ANTIBODY DRUG CONJUGATE, IN PARTICIPANTS WITH ADVANCED SOLID TUMOR MALIGNANCIES
VelaVigo Bio Inc
Summary
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts an accelerated titration for the first dose level, followed by BOIN design to identify the MTD and/or 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.
Description
Protocol Version:V1.2 Version Date:2025-11-12
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * A participant must meet all of the following inclusion criteria to be eligible to participate in this trial: * 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/metastatic 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…
Interventions
- DrugVBC101
VBC101
Locations (5)
- Start MidwestGrand Rapids, Michigan
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- NEXT OncologySan Antonio, Texas
- START Mountain Region, LLC.West Valley City, Utah
- NEXT VirginiaFairfax, Virginia