First-in-Human Trial of a VBC108 Treatment for Advanced Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label study starting with a Phase 1 dose-escalation using Bayesian optimal interval design to find the maximum tolerated dose or recommended phase 2 dose, followed by a Phase 2a dose-optimization and expansion in selected solid tumors. The trial will assess safety, tolerability, and preliminary efficacy of VBC108 across cohorts. Eligibility requires confirmed advanced solid tumors, measurable disease, good performance status, and adequate organ function, with tumor tissue available for analysis. Exclusions include significant unresolved toxicities and certain CNS-related conditions or prior specific ADC therapies.

Why it matters

Who can join: the full rules

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.

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting
• START Midwest, LLC
  Grand Rapids, Michigan, United States Recruiting
• Next Oncology - Oncology
  San Antonio, Texas, United States Recruiting
• NEXT Oncology Virginia
  Fairfax, Virginia, United States Recruiting
• GenesisCare North Shore
  St Leonards, New South Wales, Australia Recruiting
• Laura and Issac Perlmutter Cancer Center
  New York, New York, United States Not yet recruiting

Study contacts

• Study coordinator: Jun Yan
• Email: jun.yan@VelaVigo.com
• Phone: 15800359085

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.