Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab

Part of paid clinical trials in Los Angeles, California.

Sponsor
Immunocore Ltd
Study ID
NCT03973333
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Select Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMC-C103C — DRUG
    Weekly IV infusions
  • Atezolizumab — DRUG
    IV infusions every 3 weeks
  • IMC-C103C — DRUG
    Weekly subcutaneous Injection

Study Details

IMC-C103C is an immune mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen MAGE-A4. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-C103C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for MAGE-A4.

Key Dates

Start date
May 17, 2019
Status verified
Oct 2024
Primary completion
Sep 25, 2023
Completion
Sep 25, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: IMC-C103C - Monotherapy IV dose escalation
    n= approximately 50 patients to establish the MTD/expansion dose
  • Experimental: IMC-C103C and atezolizumab dose escalation
    n=approximately 12 patients to establish the MTD/expansion dose
  • Experimental: IMC-C103C - expansion
    Patients will be enrolled n=9-24 per expansion cohort (up to 4 total): metastatic/unresectable tumors of interest patients treated at the expansion dose of IMC-C103C to assess preliminary anti-tumor efficacy
  • Experimental: IMC-C103C monotherapy SC dose escalation
    Patients will be enrolled n=9-12 to establish the MTD/expansion dose

Primary Outcome Measure

Phase 1: Incidence of dose-limiting toxicities (DLT) [ Time Frame: From first dose to DLT period (28 days) ]

Locations (10)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
University of California Davis Comprehenvise Cancer CenterSacramentoCalifornia95817-
University of Colorado Cancer CenterAuroraColorado80045-
The University of Chicago Medicine & Biological SciencesChicagoIllinois60637-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Oklahoma University Medical CenterOklahoma CityOklahoma73104-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
UPMC Cancer CenterPittsburghPennsylvania15213-
Sarah Cannon Research Institute at Tennessee OncologyNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-

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