Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors

Part of paid clinical trials in La Jolla, California.

Sponsor
Immunocore Ltd
Study ID
NCT04262466
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Select Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brenetafusp — DRUG
    Brenetafusp IV infusions
  • Brenetafusp and pembrolizumab — DRUG
    Brenetafusp and pembrolizumab IV infusions
  • Brenetafusp and chemotherapy — DRUG
    Brenetafusp and chemotherapy IV infusions
  • Brenetafusp and monoclonal antibodies and chemotherapy — DRUG
    Brenetafusp and a monoclonal antibody therapy and chemotherapy
  • Brenetafusp and tebentafusp — DRUG
    Brenetafusp and tebentafusp IV infusions
  • Brenetafusp and bevacizumab — DRUG
    Brenetafusp and bevacizumab IV infusions
  • Brenetafusp and kinase inhibitors — DRUG
    Brenetafusp and oral kinase inhibitors

Study Details

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.

Key Dates

Start date
Feb 25, 2020
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
410 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Phase 1: Incidence of dose-limiting toxicity (DLT)s [ Time Frame: Up to ~28 days after each dose ]

Locations (22)

FacilityCityStateZIPSite coordinators
University of California - San DiegoLa JollaCalifornia92093-
Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
University of California Davis Comprehensive CenterSacramentoCalifornia95817-
University of ColoradoAuroraColorado80045-
Georgetown University Medical CenterWashington D.C.District of Columbia20057-
Houston Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
The University of Chicago Medical CenterChicagoIllinois60637-
University of IowaIowa CityIowa52242-
Massachusetts General HospitalBostonMassachusetts02114-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan KetteringNew YorkNew York10065-
University of Oklahoma Peggy and Charles Stephenson Cancer CenterOklahoma CityOklahoma73104-
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Prisma HealthGreenvilleSouth Carolina92697-
Sarah Cannon Research InstituteNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-
University of Utah - Huntsman Cancer InstituteSalt Lake CityUtah84112-
University of Washington - Fred Hutchinson Cancer CenterSeattleWashington98109-
University of WisconsinMadisonWisconsin53705-

Find similar trials in La Jolla, CA

By research site
University of California - San Diego· La Jolla, CAAngeles Clinic and Research Institute· Los Angeles, CAUniversity of California Davis Comprehensive Center· Sacramento, CAUniversity of Colorado· Aurora, COGeorgetown University Medical Center· Washington D.C., DCHouston Lee Moffitt Cancer Center & Research Institute· Tampa, FL

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