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

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:

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