Clinical trial · Interventional
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers
NCT04262466CI-TRIAL-00104883active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Brenetafusp (IMC-F106C) is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of brenetafusp in adult participants who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brenetafusp | Drug | — | UNRESOLVED |
| Brenetafusp and bevacizumab | Drug | — | UNRESOLVED |
| Brenetafusp and chemotherapy | Drug | — | UNRESOLVED |
| Brenetafusp and kinase inhibitors | Drug | — | UNRESOLVED |
| Brenetafusp and monoclonal antibodies and chemotherapy | Drug | — | UNRESOLVED |
| Brenetafusp and pembrolizumab | Drug | — | UNRESOLVED |
| Brenetafusp and tebentafusp | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Brenetafusp Monotherapy
- description
- Participants receive brenetafusp.
- interventionNames
- Drug: Brenetafusp
- type
- EXPERIMENTAL
- label
- Brenetafusp and Anti-PD(L)1 Agent
- description
- Participants receive brenetafusp and pembrolizumab.
- interventionNames
- Drug: Brenetafusp and pembrolizumab
- type
- EXPERIMENTAL
- label
- Brenetafusp and Chemotherapy
- description
- Participants receive brenetafusp and chemotherapy. Choice of chemotherapy is dependent on cohort.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ECOG PS 0 or 1 2. HLA-A\*02:01 positive 3. PRAME positive tumor 4. Relapsed from, refractory to, or intolerant of standard therapies; or, in combination with standard therapies 5. If applicable, must agree to use highly effective contraception Exclusion Criteria: 1. Symptomatic or untreated central nervous system metastasis 2. Recent bowel obstruction 3. Ongoing ascites or effusion requiring recent drainages 4. Significant immune-mediated adverse event with prior immunotherapy (Participants in checkpoint inhibitor combination treatment) 5. Inadequate washout from prior anticancer therapy 6. Significant ongoing toxicity from prior anticancer treatment 7. Out-of-range laboratory values 8. Clinically significant lung, heart, or autoimmune disease 9. Ongoing requirement for immunosuppressive treatment 10. Prior solid organ or bone marrow transplant 11. Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection 12. Significant secondary malignancy 13. Hypersensitivity to study drug or excipients 14. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention 15. Pregnant or lactating participants 16. Any other contraindication for applicable combination partner based on local prescribing information
References
Publications (0)
Data not yet available
No reference posted for this study.