Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This study is evaluating IMC-F106C, an immune-mobilising monoclonal T cell receptor against cancer that is designed for the treatment of cancers positive for the tumour-associated antigen PRAME. The study will be conducted in two phases:
Phase 1: Aims to identify the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of IMC-F106C as a single agent and administered in combination with a checkpoint inhibitor, chemotherapy, or another ImmTAC molecule.
Phase 2: Aims to assess the efficacy of IMC-F106C as a single agent in selected advanced solid cancers.
Conditions
This trial is treating people with advanced solid cancers that are HLA-A*02:01 and PRAME positive
Eligibility
Inclusion
- 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
- 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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Immunocore Ltd
Scientific Title
Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers
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