UPCC 26922 A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers

Investigation of Brenetafusp (IMC-F106C) for Advanced PRAME-Positive Cancers

Enrolling By Invitation
18 years or above
All
Phase 1/2
410 participants needed
1 Location

Brief description of study

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 of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Select Advanced Solid Tumors
  • Age: 18 years or above
  • Gender: All

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

This study investigates an investigational medication for people with advanced cancers that are positive for the PRAME protein. The study aims to understand the safety and effectiveness of this investigational medication in adults who have a specific genetic marker called HLA-A*02:01 and PRAME-positive tumors.

Participants in this study will receive the investigational medication either on its own or in combination with other treatments like chemotherapies, targeted therapies, and monoclonal antibodies. The study will be conducted in two phases: the first phase will determine the safest dose to use, and the second phase will evaluate how well the medication works in treating the cancer.

  • Who can participate: Adults with advanced PRAME-positive tumors who have the HLA-A*02:01 marker can participate. Participants must have a good performance status and agree to use effective contraception if applicable.
  • Study details: Participants will take part in a study where they may receive the investigational medication alone or with other treatments. An inactive substance that looks like the investigational medicine but does not contain any medicine may be used as a placebo. They need to follow the study procedures and report any side effects or health changes to the study team.
Updated on 06 Mar 2026. Study ID: 23-0087
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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