First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VBC108.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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.
Interventions
- Drug VBC108
VBC108
Primary outcome measures
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- City of Hope Medical Center — Duarte
- START Midwest, LLC — Grand Rapids
- Laura and Issac Perlmutter Cancer Center — New York
- Next Oncology - Oncology — San Antonio
- NEXT Oncology Virginia — Fairfax
China · 5 centers
- Beijing Cancer Hospital — Beijing
- Beijing GoBroad Hospital — Beijing
- Zhongshan Hospital — Shanghai
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
- Zhejiang Cancer Hospital — Hangzhou
Australia · 2 centers
- GenesisCare North Shore — St Leonards
- One Clinical Research — Perth
Identifiers
NCT: NCT07700160 · VBC108-01-01