Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
Purpose
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 patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.
Condition
- Select Advanced Solid Tumors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 (patients 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 16. Any other contraindication for applicable combination partner based on local prescribing information
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Brenetafusp Monotherapy |
Participants receive brenetafusp. |
|
|
Experimental Brenetafusp and Anti-PD(L)1 Agent |
Participants receive brenetafusp and pembrolizumab. |
|
|
Experimental Brenetafusp and Chemotherapy |
Participants receive brenetafusp and chemotherapy. Choice of chemotherapy is dependent on cohort. |
|
|
Experimental Brenetafusp and Targeted Therapy |
Participants receive brenetafusp and a selected targeted therapy. Receipt of kinase inhibitor is dependent on histology. |
|
|
Experimental Brenetafusp and Multimodal Therapy |
Participants receive brenetafusp, biologics (eg, pembrolizumab, bevacizumab) IV infusions and chemotherapy IV infusions based on histology. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Immunocore Ltd
Detailed Description
The IMC-F106C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases. 1. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of brenetafusp as a single agent and administered in combination with chemotherapies, targeted therapies, and monoclonal antibodies. 2. Phase 2: To assess the efficacy of brenetafusp in selected advanced solid tumors.