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RECRUITING
NCT07700160
PHASE1/PHASE2

First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors

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 uses Bayesian optimal interval (BOIN) design to escalate and determine 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 VBC108.

Official title: Phase 1/2a Open-label Clinical Trial Evaluating VBC108, a CLDN18.2 and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

230

Start Date

2026-07-30

Completion Date

2029-09-17

Last Updated

2026-09-01

Healthy Volunteers

No

Interventions

DRUG

VBC108

VBC108

Locations (12)

City of Hope Medical Center

Duarte, California, United States

START Midwest, LLC

Grand Rapids, Michigan, United States

Laura and Issac Perlmutter Cancer Center

New York, New York, United States

Next Oncology - Oncology

San Antonio, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

GenesisCare North Shore

St Leonards, New South Wales, Australia

One Clinical Research

Perth, Western Australia, Australia

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China