Clinical Trial

First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies

Recruiting Phase 1/2
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-08-15; most recent amendment 2026-07-21.
Status change: Not Yet Recruiting → Recruiting 2025-10-22
Trial Details
NCT Number NCT07136779
Lead Sponsor VelaVigo Bio Inc
Conditions Participants With Advanced Solid Tumor Malignancies
Enrollment 310 participants
Start Date 2025-09-23
Primary Completion 2027-07-01 (estimated)
Study Completion 2028-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-23