First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors
Sponsor: VelaVigo Bio Inc
ClinicalTrials ID:NCT07700160
This multicenter, open-label trial evaluates VBC108 in adults with advanced solid tumors. Phase 1 uses BOIN design to determine MTD/RP2D, while Phase 2a focuses on dose optimization and cohort expansion. Eligible participants must have confirmed tumors, measurable lesions, ECOG 0-1, and adequate organ function. VBC108 is administered to assess safety, tolerability, and efficacy.
Patient Parameters
| Parameter | Options |
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Program Overview
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
Inclusion Criteria
- The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
- Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor .
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.
- Male or female adults (defined as ≥ 18 years of age).
- ECOG performance status 0-1.
- Life expectancy greater than 12 weeks.
- Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
- Adequate organ and bone marrow function.
- Participants must meet the minimum washout period requirements before the first dose of investigational drug.
Exclusion Criteria
- Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.
- Known or suspected brain metastases, or spinal cord compression.
- Prior treatment with an ADC targeting CLDN18.2x CDH17 bispecific ADC.
- Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
- Prior treatment with CLDN18.2 targeting CAR-T.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Medical Center | 91010 | Duarte | California |
| START Midwest, LLC | 49546 | Grand Rapids | Michigan |
| Laura and Issac Perlmutter Cancer Center | 10016 | New York | New York |
| Next Oncology - Oncology | 78229 | San Antonio | Texas |
| NEXT Oncology Virginia | 22031 | Fairfax | Virginia |
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