Ovarian Cancer Clinical Trial
Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab
Summary
IMC-C103C is an immune mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen MAGE-A4. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-C103C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for MAGE-A4.
Full Description
The IMC-C103C-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.
To identify the MTD and/or expansion dose of IMC-C103C as a single agent administered IV and SC Q1W and administered Q1W in combination with Q3W atezolizumab.
To assess the preliminary anti-tumor activity of IMC-C103C in one or more selected indications, as a single agent administered Q1W.
Eligibility Criteria
Inclusion Criteria:
HLA-A*02:01 positive
MAGE-A4 positive tumor
ECOG PS 0 or 1
Selected advanced solid tumors
Relapsed from, refractory to, or intolerant of standard therapy
Measurable disease per RECIST v1.1 (expansion)
If applicable, must agree to use highly effective contraception
Exclusion Criteria:
Symptomatic or untreated central nervous system metastasis
Inadequate washout from prior anticancer therapy
Significant ongoing toxicity from prior anticancer treatment
Impaired baseline organ function as evaluated by out-of-range laboratory values
Clinically significant cardiac disease
Active infection requiring systemic antibiotic therapy
Known history of human immunodeficiency virus (HIV)
Active hepatitis B virus (HBV) or hepatitis C virus (HCV)
Ongoing treatment with systemic steroids or other immunosuppressive therapies
Significant secondary malignancy
Pregnancy or lactation
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There are 19 Locations for this study
Los Angeles California, 90025, United States
Sacramento California, 95817, United States
Aurora Colorado, 80045, United States
Chicago Illinois, 60637, United States
New York New York, 10065, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15213, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Barcelona , 8035, Spain
Madrid , 28027, Spain
Madrid , 28046, Spain
Pamplona , 31008, Spain
Glasgow Scotland, G12 O, United Kingdom
Bebington , CH634, United Kingdom
London , W1G 6, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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