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.
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. 1. To identify the maximum tolerated dose (MTD) and/or expansion dose of IMC-C103C as a single agent administered intravenously (IV) and subcutaneously (SC) once weekly (Q1W) and administered Q1W in combination with once every 3 weeks (Q3W) atezolizumab. 2. To assess the preliminary anti-tumor activity of IMC-C103C in one or more selected indications, as a single agent administered Q1W.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Weekly IV infusions
IV infusions every 3 weeks
Weekly subcutaneous Injection
The Angeles Clinic and Research Institute
Los Angeles, California, United States
University of California Davis Comprehenvise Cancer Center
Phase 1: Incidence of dose-limiting toxicities (DLT)
Time frame: From first dose to DLT period (28 days)
Phase 1: incidence and severity of adverse events (AE)
Time frame: from first dose to 30 days after the last dose
Phase 1: changes in laboratory parameters
Abnormalities will be classified according to NCI CTCAE v5.0
Time frame: from first dose to 30 days after the last dose
Phase 1: changes in vital signs
Abnormalities will be classified according to NCI CTCAE v5.0
Time frame: from first dose to 30 days after the last dose
Phase 1: changes in electrocardiogram parameters
QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval absolute values and changes from baseline will be summarized
Time frame: from first dose to 30 days after the last dose
Phase 1: dose interruptions, reductions, and discontinuations
Time frame: from first dose through last dose (anticipated for up to 12-24 months)
Phase 2: Best overall response (BOR)
Time frame: from first dose to approximately 2 years
Phase 2: incidence and severity of adverse events (AE)
Time frame: from first dose to 30 days after the last dose
Phase 2: changes in laboratory parameters
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Sacramento, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
The University of Chicago Medicine & Biological Sciences
Chicago, Illinois, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
...and 9 more locations
Abnormalities will be classified according to NCI CTCAE v5.0
Time frame: from first dose to 30 days after the last dose
Phase 2: changes in vital signs
Abnormalities will be classified according to NCI CTCAE v5.0
Time frame: from first dose to 30 days after the last dose
Phase 2: changes in electrocardiogram parameters
QTcF interval absolute values and changes from baseline will be summarized
Time frame: from first dose to 30 days after the last dose
Phase 2: dose interruptions, reductions, and discontinuations
Time frame: from first dose through last dose (anticipated for up to 12-24 months)
Phase 1: Best overall response
Time frame: from first dose to approximately 2 years
Progression-free survival
Time frame: from first dose to approximately 2 years
Duration of response
Time frame: from first dose to approximately 2 years
Overall survival
Time frame: from first dose to approximately 2 years
Pharmacokinetics Area under the plasma concentration-time curve (AUC)
Time frame: from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)
Pharmacokinetics The maximum observed plasma drug concentration after single dose administration (Cmax)
Time frame: from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)
Pharmacokinetics The time to reach maximum plasma concentration (Tmax)
Time frame: from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)
Pharmacokinetics The elimination half-life (t1/2)
Time frame: from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)
Immunogenicity the incidence of anti-drug antibody formation
Time frame: from first dose to 14 days after the last dose
Changes in lymphocyte counts over time
Time frame: from first dose to approx 4 weeks
Changes in serum cytokines over time
Time frame: from first dose to approx.. 4wks
GCIG CA-125 response (ovarian carcinoma)
Time frame: from first dose to approx.. 30 days after the last dose