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NCT Number: NCT07700160

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

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.

Recruiting

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

GenesisCare North Shore, St Leonards, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VBC108

Drug

VBC108

Primary outcomes

  1. 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)

    Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol

  2. Incidence of Serious Adverse Events

    Time frame: From time of Informed Consent to 30 days post last dose of VBC108

    Number of patients with serious adverse events by system organ class and preferred term

  3. Incidence of Adverse Events (AEs)

    Time frame: From time of Informed Consent to 30 days post last dose of VBC108

    Number of patients with adverse events by system organ class and preferred term

  4. Objective Response Rate (ORR)

    Time frame: From first dose of VBC108 to disease progression or death, up to approximately 2 years

    The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Yan

CONTACT

[email protected]

15800359085

Sponsors and collaborators

Lead sponsor

VelaVigo Bio Inc

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 13, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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