Trials / Active Not Recruiting
Active Not RecruitingNCT04262466
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
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 410 (actual)
- Sponsor
- Immunocore Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brenetafusp | Brenetafusp IV infusions |
| DRUG | Brenetafusp and pembrolizumab | Brenetafusp and pembrolizumab IV infusions |
| DRUG | Brenetafusp and chemotherapy | Brenetafusp and chemotherapy IV infusions |
| DRUG | Brenetafusp and monoclonal antibodies and chemotherapy | Brenetafusp and a monoclonal antibody therapy and chemotherapy |
| DRUG | Brenetafusp and tebentafusp | Brenetafusp and tebentafusp IV infusions |
| DRUG | Brenetafusp and bevacizumab | Brenetafusp and bevacizumab IV infusions |
| DRUG | Brenetafusp and kinase inhibitors | Brenetafusp and oral kinase inhibitors |
Timeline
- Start date
- 2020-02-25
- Primary completion
- 2026-10-01
- Completion
- 2027-12-01
- First posted
- 2020-02-10
- Last updated
- 2026-03-06
Locations
76 sites across 17 countries: United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Ireland, Italy, Netherlands, New Zealand, Poland, South Korea, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04262466. Inclusion in this directory is not an endorsement.