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

About the study

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.

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 therapies; or, in combination with standard therapies
If applicable, must agree to use highly effective contraception

EXCLUSION CRITERIA

Exclusion Criteria:

Symptomatic or untreated central nervous system metastasis
Recent bowel obstruction
Ongoing ascites or effusion requiring recent drainages
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), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
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