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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
727
Brenetafusp IV infusions
Brenetafusp and pembrolizumab IV infusions
Brenetafusp and chemotherapy IV infusions
Phase 1: Incidence of dose-limiting toxicity (DLT)s
Time frame: Up to ~28 days after each dose
Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE)
Time frame: Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuations
Time frame: Up to ~12 months
Phase 1: Number of participants with abnormal laboratory test results (hematology)
Time frame: Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with abnormal laboratory test results (chemistry)
Time frame: Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with abnormal laboratory test results (coagulation)
Time frame: Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with abnormal urinalysis
Time frame: Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with abnormal vital signs
Time frame: Up to 30 days after the last dose of study therapy
Phase 1: Mean change from baseline in QTcF interval
Time frame: Up to 30 days after the last dose of study therapy
Phase 2: Best overall response (BOR)
Time frame: Up to ~2 years
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Brenetafusp and a monoclonal antibody therapy and chemotherapy
Brenetafusp and tebentafusp IV infusions
Brenetafusp and bevacizumab IV infusions
Brenetafusp and oral kinase inhibitors
University of California - San Diego
La Jolla, California, United States
RECRUITINGAngeles Clinic and Research Institute
Los Angeles, California, United States
RECRUITINGUniversity of California Davis Comprehensive Center
Sacramento, California, United States
RECRUITINGUniversity of Colorado
Aurora, Colorado, United States
RECRUITINGGeorgetown University Medical Center
Washington D.C., District of Columbia, United States
ACTIVE_NOT_RECRUITINGHouston Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
RECRUITINGThe University of Chicago Medical Center
Chicago, Illinois, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGJohn Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
COMPLETED...and 66 more locations
Phase I: Best Overall Response (BOR)
Time frame: Up to ~2 years
Progression-free survival (PFS)
Time frame: Up to ~2 years
Duration of response (DOR)
Time frame: Up to ~2 years
Overall survival
Time frame: Up to ~2 years
Area under the plasma concentration-time curve (AUC) of brenetafusp
Time frame: At designated time points up to ~3 weeks
Maximum plasma drug concentration (Cmax) of brenetafusp
Time frame: At designated time points up to ~3 weeks
Time to reach maximum plasma concentration (Tmax) of brenetafusp
Time frame: At designated time points up to ~3 weeks
Plasma elimination half-life (t½) of brenetafusp
Time frame: At designated time points up to ~3 weeks
Incidence of anti-brenetafusp antibody formation
Time frame: Up to ~ 2 years
Changes in lymphocyte counts over time
Time frame: Up to ~3 weeks
Changes in serum cytokines over time
Time frame: Up to ~3 weeks
Local tumor response based on Gynecological Cancer Intergroup (GCIG) Cancer Antigen 25 (CA-125) response criteria
Time frame: Up to ~2 years