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

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: VelaVigo Bio Inc · Participants: 230 · Started: Jul 30, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07700160

Locations in the U.S.

CaliforniaCity of Hope Medical Center, Duarte
MichiganSTART Midwest, LLC, Grand Rapids
New YorkLaura and Issac Perlmutter Cancer Center, New York (Not yet recruiting)
TexasNext Oncology - Oncology, San Antonio
VirginiaNEXT Oncology Virginia, Fairfax

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.