Description:
IMC-C103C is an immune mobilizing 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.
Title
- Brief Title: Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab
- Official Title: A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as Single Agent and in Combination With Atezolizumab in HLA-A*0201-positive Patients With Advanced MAGE-A4-positive Cancer
Clinical Trial IDs
- ORG STUDY ID:
IMC-C103C-101
- NCT ID:
NCT03973333
Conditions
- NSCLC
- Esophageal Cancer
- Gastric Cancer
- Head and Neck Squamous Cell Carcinoma
- Urothelial Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
IMC-C103C | | IMC-C103C - Arm A1 |
Atezolizumab | | IMC-C103C and atezolizumab Arm A2 |
Purpose
IMC-C103C is an immune mobilizing 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.
Detailed Description
The IMC-C103C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable
tumors of interest which include NSCLC, esophageal carcinoma, gastric carcinoma, HNSCC, and
urothelial carcinoma and will be conducted in two phases.
1. A Phase 1 dose escalation study to identify the MTD/RP2D of IMC-C103C as monotherapy
(Arm A1) and IMC-C103C in combination with atezolizumab (Arm A2)
2. A Phase 2 dose expansion cohort study to further characterize the safety and
tolerability of IMC-C103C monotherapy (Arm B1) or in combination with atezolizumab (Arm
B2).
Trial Arms
Name | Type | Description | Interventions |
---|
IMC-C103C - Arm A1 | Experimental | n= approximately 35 NSCLC, esophageal carcinoma, gastric carcinoma, HNSCC, and urothelial carcinoma patients to establish the MTD/RP2D | |
IMC-C103C and atezolizumab Arm A2 | Experimental | n=approximately 21 NSCLC, esophageal carcinoma, gastric carcinoma, HNSCC, and urothelial carcinoma patients to establish the MTD/RP2D | |
IMC-C103C - Arm B1 | Experimental | Patients will be enrolled n=20 metastatic/unresectable tumors of interest which include NSCLC, esophageal carcinoma, gastric carcinoma, HNSCC, and urothelial carcinoma patients treated at the RP2D of IMC-C103C characterize the safety and tolerability of IMC-C103C | |
IMC-C103C and atezolizumab Arm B2 | Experimental | Patients will be enrolled n=20 metastatic/unresectable tumors of interest which include NSCLC, esophageal carcinoma, gastric carcinoma, HNSCC, and urothelial carcinoma patients treated at the RP2D of IMC-C103C characterize the safety and tolerability of IMC-C103C in combination with atezolizumab | |
Eligibility Criteria
Inclusion Criteria:
1. Male or female patients age ≥ 18 years of age at the time of informed consent
2. HLA-A*0201 positive, confirmed by central laboratory
3. MAGE-A4 positive tumor confirmed by the central laboratory
4. Histologically confirmed diagnosis of metastatic/unresectable NSCLC, esophageal,
gastric, urothelial, and HNSCC cancers are eligible
5. Prior Treatments:
- Arms A1 and A2 — patients must be relapsed from, refractory to, or intolerant to
all approved classes of therapy for their disease. There is no limit on the
number of prior therapies
- Arms B1 and B2 — patients must have experienced disease progression or drug
intolerance in the unresectable/metastatic setting following at least one line of
chemotherapy AND one line of immune therapy as designated by the standard of care
for a particular disease. There is no limit on the number of prior therapies.
- Special consideration: NSCLC patients with known mutations (ie, EGFR, ROS, ALK,
B-Raf proto-oncogene serine/threonine kinase [BRAF]) must have experienced
disease progression or drug intolerance following at least one line of small
molecule targeted therapy and following platinum-based chemotherapy.
6. Disease amenable to pre-treatment biopsy if no archival tissue available
7. Measurable disease to RECIST v.1.1 criteria
Exclusion Criteria:
1. Impaired baseline organ function as evaluated by out-of-range laboratory values
2. History of severe hypersensitivity reactions (eg, anaphylaxis) to monoclonal
antibodies
3. Clinically significant cardiac disease or impaired cardiac function
4. Presence of symptomatic or untreated central nervous system (CNS) metastases
5. Active infection requiring systemic antibiotic therapy
6. Known history of human immunodeficiency virus infection (HIV)
7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
8. Malignant disease, other than that being treated in this study
9. Patients receiving systemic steroid therapy or any other systemic immunosuppressive
medication. Local steroid therapies are acceptable
10. Systemic anti-cancer therapy within 2 weeks of the first dose of study drug.
11. Major surgery within 2 weeks of the first dose of study drug
12. Radiotherapy within 2 weeks of the first dose of study drug, with the exception of
palliative radiotherapy to a limited field
13. Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ≤ 2
weeks prior to start of study drug
14. Pregnant, likely to become pregnant, or lactating women
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Recommended Phase 2 dose (RP2D) |
Time Frame: | day 1 to day 21 |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Immunocore Ltd |
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