Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Immunocore Ltd
- Study ID
- NCT03973333
- Phase
- PHASE1/PHASE2
- Status
- Withdrawn
Conditions
- Select Advanced Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- IMC-C103C — DRUGWeekly IV infusions
- Atezolizumab — DRUGIV infusions every 3 weeks
- IMC-C103C — DRUGWeekly subcutaneous Injection
Study Details
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.
Key Dates
- Start date
- May 17, 2019
- Status verified
- Oct 2024
- Primary completion
- Sep 25, 2023
- Completion
- Sep 25, 2023
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: IMC-C103C - Monotherapy IV dose escalationn= approximately 50 patients to establish the MTD/expansion dose
- Experimental: IMC-C103C and atezolizumab dose escalationn=approximately 12 patients to establish the MTD/expansion dose
- Experimental: IMC-C103C - expansionPatients will be enrolled n=9-24 per expansion cohort (up to 4 total): metastatic/unresectable tumors of interest patients treated at the expansion dose of IMC-C103C to assess preliminary anti-tumor efficacy
- Experimental: IMC-C103C monotherapy SC dose escalationPatients will be enrolled n=9-12 to establish the MTD/expansion dose
Primary Outcome Measure
Phase 1: Incidence of dose-limiting toxicities (DLT) [ Time Frame: From first dose to DLT period (28 days) ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Angeles Clinic and Research Institute | Los Angeles | California | 90025 | - |
| University of California Davis Comprehenvise Cancer Center | Sacramento | California | 95817 | - |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | - |
| The University of Chicago Medicine & Biological Sciences | Chicago | Illinois | 60637 | - |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | - |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | - |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | - |
| UPMC Cancer Center | Pittsburgh | Pennsylvania | 15213 | - |
| Sarah Cannon Research Institute at Tennessee Oncology | Nashville | Tennessee | 37203 | - |
| MD Anderson Cancer Center | Houston | Texas | 77030 | - |
Find similar trials in Los Angeles, CA
By research site
The Angeles Clinic and Research Institute· Los Angeles, CAUniversity of California Davis Comprehenvise Cancer Center· Sacramento, CAUniversity of Colorado Cancer Center· Aurora, COThe University of Chicago Medicine & Biological Sciences· Chicago, ILMemorial Sloan Kettering Cancer Center· New York, NYOklahoma University Medical Center· Oklahoma City, OK
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