Clinical Trial 24095

• Overview

  Study Title:

  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:

  The main goal of this study is to test if the study drug (VBC101) is safe and tolerable in participants with advanced or metastatic solid tumors, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and head and neck squamous cell carcinoma (HNSCC). The study will also measure the study drug's levels in patient blood at different time points (known as PK), determine whether the body produces antibodies against the study drug (known as ADA), and assess the study drug's effect on the disease. Additionally, the study may explore the relationship between biomarkers (biological molecules in tumor tissue that may indicate disease characteristics) and how effectively the study drug works for patients.

  Objective:

  Primary Objectives: Phase 1 (Dose Escalation and Backfill) - To evaluate the safety and tolerability of VBC101 - To determine the MTD and/or the RP2D of VBC101 Phase 2a (Dose Optimization and Cohort Expansion) - To assess the safety and tolerability of VBC101 in targeted participant populations. - To assess the effectiveness of VBC101 by assessment of ORR Secondary Objectives: Phase 1 (Dose Escalation and Backfill) - To assess the preliminary antitumor activity of VBC101. - To characterize the PK of VBC101 (ADC, total anti-EGFR cMet antibody, unconjugated payload exatecan). - To assess the immunogenicity of VBC101 in targeted participants Phase 2a (Dose Optimization and Cohort Expansion) - To further assess the PK of VBC101(VBC101 ADC, total anti-EGFR-cMet antibody, unconjugated payload exatecan). - To evaluate the prevalence and incidence of ADA against VBC101 in serum via a validated assay. - To evaluate the preliminary efficacy of VBC101 with additional efficacy parameters.

• Treatments

  Therapies:

  cMet/EGFR-targeting bispecific Antibody drug conjugate

  Medications:

  VBC101 ()

• Inclusion Criteria

  Inclusion Criteria: A participant must meet all of the following inclusion criteria to be eligible to participate in this trial:
  • 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 that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or for which no standard treatment is available
  • At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria
  • Male or female adults (defined as ≥ 18 years of age)
  • ECOG performance status 0-1
  • Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.
  • 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

  Exclusion Criteria:
  • Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment, except for alopecia, neuropathy, or skin pigmentation changes. Participants with chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the study investigator and the Sponsor's Medical Monitor.
  • Known or suspected brain metastases, or spinal cord compression, unless the condition has been treated, asymptomatic, and has been stable without requiring escalating doses of corticosteroids (equivalent to ≤10 mg/day prednisone) or anti-convulsant medications for at least four weeks prior for the first dose of investigational drug.
  • Prior treatment with an ADC targeting EGFR and/or cMet (including VBC101)
  • Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101).
  • Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
  • Other exclusions may apply

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