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

Trial Status: Active

IMC-C103C is an immune mobilizing 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.

Inclusion Criteria

  • HLA-A*02:01 positive
  • MAGE-A4 positive tumor
  • ECOG PS 0 or 1
  • Selected advanced solid tumors
  • Relapsed from, refractory to, or intolerant of standard therapy
  • Measurable disease per RECIST v1.1
  • If applicable, must agree to use highly effective contraception

Exclusion Criteria

  • Symptomatic or untreated central nervous system metastasis
  • Inadequate washout from prior anticancer therapy
  • Significant ongoing toxicity from prior anticancer treatment
  • Impaired baseline organ function as evaluated by out-of-range laboratory values
  • Clinically significant cardiac disease
  • Active infection requiring systemic antibiotic therapy
  • Known history of human immunodeficiency virus (HIV)
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Ongoing treatment with systemic steroids or other immunosuppressive therapies
  • Significant secondary malignancy
  • Pregnancy or lactation

Colorado

Aurora
University of Colorado Hospital
Status: APPROVED

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: APPROVED
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: George Richard Blumenschein
Phone: 713-792-6363

The IMC-C103C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases. 1. To identify the MTD and/or RP2D of IMC-C103C as a single agent administered Q1W (Arm A1) and administered Q1W in combination with Q3W atezolizumab (Arm A2). 2. To assess the preliminary anti-tumor activity of IMC C103C in one or more selected indications, as a single agent administered Q1W (Arm B1) and administered Q1W in combination with Q3W atezolizumab (Arm B2).

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Immunocore Ltd

  • Primary ID IMC-C103C-101
  • Secondary IDs NCI-2019-04436
  • Clinicaltrials.gov ID NCT03973333