Overview
The IMC-F106C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases. 1. Phase 1: 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 chemotherapies, targeted therapies, and monoclonal antibodies. 2. Phase 2: To assess the efficacy of IMC-F106C in selected advanced solid tumors.
Principal investigator
Eligibility 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:
- 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
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