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RECRUITING
NCT07136779
PHASE1/PHASE2

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

Sponsor: VelaVigo Bio Inc

View on ClinicalTrials.gov

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

DRUG

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