Clinical trial · Interventional
Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study withdrawn by Sponsor
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Select Advanced Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| IMC-C103C | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- IMC-C103C - Monotherapy IV dose escalation
- description
- n= approximately 50 patients to establish the MTD/expansion dose
- interventionNames
- Drug: IMC-C103C
- type
- EXPERIMENTAL
- label
- IMC-C103C and atezolizumab dose escalation
- description
- n=approximately 12 patients to establish the MTD/expansion dose
- interventionNames
- Drug: IMC-C103C
- Drug: Atezolizumab
- type
- EXPERIMENTAL
- label
- IMC-C103C - expansion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSweis RF, Melero I, Davar D, Garralda E, Hamid O, Chen HA, Evans TRJ, Moore KN, Sacco JJ, Thistlethwaite F, Williams A, Blumenschein GR, Callahan MK, Johnson ML, Schenk EL, Wustner J, Stanhope S, Tao K, Marshall S, Lopez J. Phase 1/2 study of IMC-C103C, a T cell receptor bispecific (MAGE-A4xCD3) ImmTAC targeting MAGE-A4-expressing malignancies. J Immunother Cancer. 2026 Jul 20;14(7):e014638. doi: 10.1136/jitc-2025-014638. PMID 42476725