Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
About the study
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 IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- ECOG PS 0 or 1
- HLA-A*02:01 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
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 checkpoint inhibitor combination treatment)
- Inadequate washout from prior anticancer therapy
- Significant ongoing toxicity from prior anticancer treatment
- Out-of-range laboratory values
- Clinically significant lung, heart, or autoimmune 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
- Any other contraindication for applicable combination partner based on local prescribing information
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Select Advanced Solid Tumors
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
170
Est. Completion Date
Feb 28, 2026
Treatment type
Interventional
Sponsor
Immunocore Ltd
ClinicalTrials.gov identifier
NCT04262466
Study number
IMC-F106C-101
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