Melanoma Clinical Trial
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
Summary
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
Full Description
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.
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 a checkpoint Inhibitor, chemotherapy, or another ImmTAC molecule.
Phase 2: To assess the efficacy of IMC-F106C as a single agent in selected advanced solid tumors.
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 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
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There are 29 Locations for this study
Scottsdale Arizona, 85258, United States
Irvine California, 92697, United States
La Jolla California, 92093, United States
Los Angeles California, 90025, United States
Sacramento California, 95817, United States
San Francisco California, 94143, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20057, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
Iowa City Iowa, 52242, United States
Boston Massachusetts, 02114, United States
Hackensack New Jersey, 07601, United States
New York New York, 10032, United States
New York New York, 10065, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98109, United States
Madison Wisconsin, 53705, United States
London City Of London, W1G6A, United Kingdom
Oxford Oxfordshire, OX3 7, United Kingdom
London , W1T7H, United Kingdom
Manchester , , United Kingdom
Surrey Quays , SM25P, United Kingdom
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