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

ClinicalTrials.gov ID

NCT07700160

Lead Sponsor

VelaVigo Bio IncINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 1Phase 2

Enrollment

230Estimated

Last Update Posted

Sep 1, 2026Actual

Start Date

Jul 30, 2026Actual

Primary Completion Date

Jul 7, 2029Estimated

Completion Date

Sep 17, 2029Estimated

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

Brief 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.

• Advanced Solid Tumors

• VBC108

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

VelaVigo Bio IncINDUSTRY

sreenivasa.chandana@startmidwest.com16169545554

mohamad.salkeni@usoncology.com7032083159

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