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First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2025-09-23
Completion Date
2028-07-01
Last Updated
2026-01-30
Healthy Volunteers
No
Interventions
VBC101
VBC101
Locations (5)
Start Midwest
Grand Rapids, Michigan, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
START Mountain Region, LLC.
West Valley City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States