Recruiting
Phase 1
Phase 2

VBC108

Sponsor:

VelaVigo Bio Inc

Code:

NCT07700160

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VBC108

Study Details

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.

Conditions

Advanced Solid Tumors

Study ID

NCT07700160

Start date

Jul 30, 2026

Status verified date

Aug, 2026

Completion date

Sep 17, 2029

Anticipated

Primary completion date

Jul 7, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

230 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VBC108 Dose Level 1

Phase 1 dose escalation and backfill: VBC108 at Dose Level 1

experimental: VBC108 Dose Level 2

Phase 1 dose escalation and backfill: VBC108 at Dose Level 2

experimental: VBC108 Dose Level 3

Phase 1 dose escalation and backfill: VBC108 at Dose Level 3

experimental: VBC108 Dose Level 4

Phase 1 dose escalation and backfill: VBC108 at Dose Level 4

experimental: VBC108 Dose Level 5

Phase 1 dose escalation and backfill: VBC108 at Dose Level 5

experimental: VBC108 Dose Level recommended Phase 2 dose (RP2D)

Phase 2a expansion cohort: VBC108 at recommended Phase 2 dose (RP2D) across tumor-specific cohorts

Interventions

VBC108

VBC108

Primary outcome measure

  • Incidence of dose-limiting toxicities (DLT) as defined in the protocol [ Time Frame: From time of first dose of VBC108 to end of DLT period ( 21 days) ]
  • Incidence of Serious Adverse Events [ Time Frame: From time of Informed Consent to 30 days post last dose of VBC108 ]
  • Incidence of Adverse Events (AEs) [ Time Frame: From time of Informed Consent to 30 days post last dose of VBC108 ]
  • Objective Response Rate (ORR) [ Time Frame: From first dose of VBC108 to disease progression or death, up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

START Midwest, LLC

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Next Oncology - Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

More Information

Sponsor

VelaVigo Bio Inc

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VelaVigo Bio Inc on 2026-09-01.