Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors

Sponsor: Immunocore Ltd

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04262466

Patient View

The IMC-F106C-101 Phase 1/2 trial evaluates IMC-F106C in adults with PRAME-positive, HLA-A2 tumors. Phase 1 identifies the MTD/RP2D, while Phase 2 assesses efficacy. Eligible patients have ECOG PS 0-1 and must meet specific criteria. Exclusions include CNS metastasis and significant immune issues. Interventions include IMC-F106C alone or with various therapies.

Patient Parameters

Program Overview

Brenetafusp (IMC-F106C) is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of brenetafusp in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.

Description

The IMC-F106C-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. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of brenetafusp as a single agent and administered in combination with chemotherapies, targeted therapies, and monoclonal antibodies.
  2. Phase 2: To assess the efficacy of brenetafusp in selected advanced solid tumors.

Eligibility Criteria

Inclusion Criteria

  1. ECOG PS 0 or 1
  2. HLA-A*02:01 positive
  3. PRAME positive tumor
  4. Relapsed from, refractory to, or intolerant of standard therapies; or, in combination with standard therapies
  5. If applicable, must agree to use highly effective contraception

Exclusion Criteria

  1. Symptomatic or untreated central nervous system metastasis
  2. Recent bowel obstruction
  3. Ongoing ascites or effusion requiring recent drainages
  4. Significant immune-mediated adverse event with prior immunotherapy (patients in checkpoint inhibitor combination treatment)
  5. Inadequate washout from prior anticancer therapy
  6. Significant ongoing toxicity from prior anticancer treatment
  7. Out-of-range laboratory values
  8. Clinically significant lung, heart, or autoimmune disease
  9. Ongoing requirement for immunosuppressive treatment
  10. Prior solid organ or bone marrow transplant
  11. Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
  12. Significant secondary malignancy
  13. Hypersensitivity to study drug or excipients
  14. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
  15. Pregnant or lactating
  16. Any other contraindication for applicable combination partner based on local prescribing information

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