PHASE 1/2A OPEN-LABEL CLINICAL TRIAL EVALUATING VBC101, AN EGFR AND CMET TARGETED BI-SPECIFIC ANTIBODY DRUG CONJUGATE, IN PARTICIPANTS WITH ADVANCED SOLID TUMOR MALIGNANCIES
Summary
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts an accelerated titration for the first dose level, followed by BOIN design to identify 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 VBC101.
Detailed description
Protocol Version:V1.2 Version Date:2025-11-12
Arms & interventions
- DrugVBC101
VBC101
Outcome measures
Primary
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Time frame: (DLT)From time of first dose of VBC101 to end of DLT period (approximately 21 days)
Incidence of Serious Adverse Events
Number of patients with serious adverse events by system organ class and preferred term
Time frame: From time of Informed Consent to 30 days post last dose of VBC101
Incidence of Adverse Events (AEs)
Number of patients with adverse events by system organ class and preferred term
Time frame: From time of Informed Consent to 30 days post last dose of VBC101
Secondary
Objective Response Rate (ORR)
Time frame: From date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Duration of Response (DoR)
Time frame: From date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Disease Control Rate (DCR) at 12 weeks
Time frame: From date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks)
Progression free Survival (PFS)
Time frame: From date of first dose of VBC101 up until date of progression or death due to any cause (approximately 2 years)
Overall Survival (OS)
Time frame: From date of first dose of VBC101 up until the date of death due to any cause (approximately 2 years)
Pharmacokinetics of VBC101: Plasma PK concentrations
Time frame: From date of first dose of VBC101 up until 30 days post last dose
Pharmacokinetics of VBC101: Area under the concentration time curve (AUC)
Time frame: From date of first dose of VBC101 up until 30 days post last dose
Pharmacokinetics of VBC101: Maximum plasma concentration of the study drug (C-max)
Time frame: From date of first dose of VBC101 up until 30 days post last dose
Pharmacokinetics of VBC101: Time to maximum plasma concentration of the study drug (T-max)
Time frame: From date of first dose of VBC101 up until 30 days post last dose
Pharmacokinetics of VBC101: Half-life
Time frame: From date of first dose of VBC101 up until 30 days post last dose
Immunogenicity of VBC101: Anti-Drug Antibodies (ADA)
Time frame: From date of first dose of VBC101 up until 30 days post last dose
Eligibility criteria
Study locations (5)
Start Midwest
Grand Rapids, Michigan, 49546
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Oncology
San Antonio, Texas, 78229
START Mountain Region, LLC.
West Valley City, Utah, 84119
NEXT Virginia
Fairfax, Virginia, 22031