Clinical trial
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
Name
IMC-C103C-101
Description
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.
Trial arms
Trial start
2019-05-17
Estimated PCD
2023-09-25
Trial end
2023-09-25
Status
Terminated
Phase
Early phase I
Treatment
IMC-C103C
Weekly IV infusions
Arms:
IMC-C103C - Monotherapy IV dose escalation, IMC-C103C - expansion, IMC-C103C and atezolizumab dose escalation
Atezolizumab
IV infusions every 3 weeks
Arms:
IMC-C103C and atezolizumab dose escalation
Other names:
TECENTRIQ
IMC-C103C
Weekly subcutaneous Injection
Arms:
IMC-C103C monotherapy SC dose escalation
Size
75
Primary endpoint
Phase 1: Incidence of dose-limiting toxicities (DLT)
From first dose to DLT period (28 days)
Phase 1: incidence and severity of adverse events (AE)
from first dose to 30 days after the last dose
Phase 1: changes in laboratory parameters
from first dose to 30 days after the last dose
Phase 1: changes in vital signs
from first dose to 30 days after the last dose
Phase 1: changes in electrocardiogram parameters
from first dose to 30 days after the last dose
Phase 1: dose interruptions, reductions, and discontinuations
from first dose through last dose (anticipated for up to 12-24 months)
Phase 2: Best overall response (BOR)
from first dose to approximately 2 years
Eligibility criteria
Inclusion Criteria:
1. HLA-A\*02:01 positive
2. MAGE-A4 positive tumor
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \[ECOG PS\] 0 or 1
4. Selected advanced solid tumors
5. Relapsed from, refractory to, or intolerant of standard therapy
6. Measurable disease per RECIST v1.1 (expansion)
7. If applicable, must agree to use highly effective contraception
Exclusion Criteria:
1. Symptomatic or untreated central nervous system metastasis
2. Inadequate washout from prior anticancer therapy
3. Significant ongoing toxicity from prior anticancer treatment
4. Impaired baseline organ function as evaluated by out-of-range laboratory values
5. Clinically significant cardiac disease
6. Active infection requiring systemic antibiotic therapy
7. Known history of human immunodeficiency virus (HIV)
8. Active hepatitis B virus (HBV) or hepatitis C virus (HCV)
9. Ongoing treatment with systemic steroids or other immunosuppressive therapies
10. Significant secondary malignancy
11. Pregnancy or lactation
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Sequential from arm monotherapy IV dose escalation is opened first; then monotherapy SC dose escalation, monotherapy expansion and combination dose escalation may run', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}
Updated at
2024-03-07
1 organization
2 products
1 indication
Organization
ImmunocoreProduct
IMC-C103CIndication
solid tumorsProduct
Atezolizumab