Overview

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

Eligibility

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 therapy
5. If applicable, must agree to use highly effective contraception
6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol

Exclusion Criteria:

1. Symptomatic or untreated central nervous system metastasis
2. Recent bowel obstruction
3. Ascites requiring recurrent paracentesis
4. Significant immune-mediated adverse event with prior immunotherapy (patients in 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 cardiac disease
9. Ongoing requirement for immunosuppressive treatment
10. Prior solid organ or bone marrow transplant
11. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
12. Known history of human immunodeficiency virus (HIV)
13. Significant secondary malignancy
14. Hypersensitivity to study drug or excipients
15. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
16. Pregnant or lactating