Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immunocore Ltd
• Treatments: Antibodies, Monoclonal; Atezolizumab

Criteria

Inclusion Criteria:

1. HLA-A*02:01 positive

2. MAGE-A4 positive tumor

3. 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