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NCT07700160PHASE1, PHASE2Recruiting

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

VelaVigo Bio Inc

Start Date

7/30/2026

Completion Date

9/17/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 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 . 3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria. 4. Male or female adults (defined as ≥ 18 years of age). 5. ECOG performance status 0-1. 6. Life expectancy greater than 12 weeks. 7. Archived tumor tissue sample available or able to undergo a fresh biopsy collection. 8. Adequate organ and bone marrow function. 9. Participants must meet the minimum washout period requirements before the first dose of investigational drug. Exclusion Criteria: 1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment. 2. Known or suspected brain metastases, or spinal cord compression. 3. Prior treatment with an ADC targeting CLDN18.2x CDH17 bispecific ADC. 4. Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload. 5. Prior treatment with CLDN18.2 targeting CAR-T.

Interventions

DRUG

VBC108

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Conditions

Advanced Solid Tumors

Locations

City of Hope Medical Center

Duarte, California 91010

United States

START Midwest, LLC

Grand Rapids, Michigan 49546

United States

Laura and Issac Perlmutter Cancer Center

New York, New York 10016

United States

Next Oncology - Oncology

San Antonio, Texas 78229

United States

NEXT Oncology Virginia

Fairfax, Virginia 22031

United States

GenesisCare North Shore

St Leonards, New South Wales 2065

Australia

One Clinical Research

Perth, Western Australia 6009

Australia

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142

China

Beijing GoBroad Hospital

Beijing, Beijing Municipality 102200

China

Zhongshan Hospital

Shanghai, Shanghai Municipality 200032

China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang 310009

China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang 310022

China