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

Study Identifier:
VBC108-01-01
CT.gov Identifier:
NCT07700160
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Will Be Recruiting

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: VBC108 Dose Level 1
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Drug: Phase 1 dose escalation and backfill: VBC108 at Dose Level 1
Drug: Drug: VBC108
Drug: VBC108
Drug: EXPERIMENTAL: VBC108 Dose Level 2
Drug: Phase 1 dose escalation and backfill: VBC108 at Dose Level 2
Drug: EXPERIMENTAL: VBC108 Dose Level 3
Drug: Phase 1 dose escalation and backfill: VBC108 at Dose Level 3
Drug: EXPERIMENTAL: VBC108 Dose Level 4
Drug: Phase 1 dose escalation and backfill: VBC108 at Dose Level 4
Drug: EXPERIMENTAL: VBC108 Dose Level 5
Drug: Phase 1 dose escalation and backfill: VBC108 at Dose Level 5
Drug: EXPERIMENTAL: VBC108 Dose Level recommended Phase 2 dose (RP2D)
Drug: Phase 2a expansion cohort: VBC108 at recommended Phase 2 dose (RP2D) across tumor-specific cohorts
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Sreenivasa Chandana
Status
Will Be Recruiting
Condition(s) Treated at Site