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

Launched by IMMUNOCORE LTD · Feb 7, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called brenetafusp (IMC-F106C) for adult patients with certain types of advanced solid tumors that have a specific marker called PRAME. The goal is to find out how safe and effective this treatment is when given alone or in combination with other cancer therapies known as checkpoint inhibitors. This is the first time this treatment is being tested in humans, and researchers are looking for participants who have the right tissue marker (HLA-A*02:01) and have already tried standard treatments without success or cannot tolerate them.

To join the trial, participants should be adults between the ages of 18 and 75, have a specific performance status (ECOG PS 0 or 1, meaning they are mostly active and able to carry out daily activities), and have tumors that test positive for both PRAME and the HLA marker. Participants can expect regular check-ups and monitoring throughout the trial to ensure their safety. However, there are some health conditions that could prevent someone from participating, such as active infections, recent major surgeries, or severe side effects from previous cancer treatments. If you or someone you know might be interested in this study, it's a good idea to talk to a healthcare provider for more information.

Gender

ALL

Eligibility 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