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

  • STATUS
    Recruiting
  • participants needed
    170
  • sponsor
    Immunocore Ltd
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Updated on 19 February 2024
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Summary

IMC-F106C is an immune-mobilizing 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 IMC-F106C 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 IMC-F106C as a single agent (Arm A) and administered in combination with Checkpoint Inhibitors (Arm B).
  2. Phase 2: To assess the preliminary anti-tumor activity of IMC-F106C in up to 4 indications, as a single agent administration.

Details
Condition Select Advanced Solid Tumors
Age 18years - 100years
Treatment IMC-F106C, anti-PD(L)1
Clinical Study IdentifierNCT04262466
SponsorImmunocore Ltd
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

ECOG PS 0 or 1
HLA-A02:01 positive
PRAME positive tumor
Relapsed from, refractory to, or intolerant of standard therapy
If applicable, must agree to use highly effective contraception
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol

Exclusion Criteria

Symptomatic or untreated central nervous system metastasis
Recent bowel obstruction
Ascites requiring recurrent paracentesis
Significant immune-mediated adverse event with prior immunotherapy (patients in combination treatment)
Inadequate washout from prior anticancer therapy
Significant ongoing toxicity from prior anticancer treatment
Out-of-range laboratory values
Clinically significant cardiac disease
Ongoing requirement for immunosuppressive treatment
Prior solid organ or bone marrow transplant
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Known history of human immunodeficiency virus (HIV)
Significant secondary malignancy
Hypersensitivity to study drug or excipients
Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
Pregnant or lactating
Clear my responses
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