Home › Trials › NCT04262466

Evaluating a new cancer treatment using brenetafusp for advanced solid tumors

Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers

Phase1; Phase2 Interventional Immunocore Ltd · NCT04262466

This study is testing a new cancer treatment called brenetafusp to see if it can safely help people with advanced solid tumors that have a specific marker.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment727 (estimated)
Ages18 Years and up
SexAll
SponsorImmunocore Ltd Industry-sponsored
Drugs / interventionsimmunotherapy
Locations76 sites (La Jolla, California and 75 other locations)
Trial IDNCT04262466 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of brenetafusp (IMC-F106C), an immune-mobilizing monoclonal T cell receptor designed to target cancers expressing the PRAME antigen. The study is divided into two phases: Phase 1 focuses on determining the maximum tolerated dose of brenetafusp as a standalone treatment and in combination with other therapies, while Phase 2 assesses its effectiveness in patients with advanced solid tumors. Participants must have the HLA-A2 tissue marker and a PRAME-positive tumor, and they will be monitored for safety and treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced solid tumors who are HLA-A*02:01 positive and have PRAME-positive tumors.

Not a fit: Patients with untreated central nervous system metastasis or significant ongoing health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that express the PRAME antigen.

How similar studies have performed: While this approach is novel, similar immunotherapy strategies have shown promise in treating various cancers, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 (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

Where this trial is running

La Jolla, California and 75 other locations

+26 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Select Advanced Solid Tumors
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.