ASP8374 + Cemiplimab for Recurrent Brain Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, there are specific time periods that must pass after certain treatments before starting the study, such as 4 weeks from cytotoxic therapy and 6 weeks from antibodies. It's best to discuss your current medications with the study team to understand how they might affect your eligibility.
What data supports the effectiveness of the drug combination ASP8374 and Cemiplimab for recurrent brain cancer?
Cemiplimab has shown effectiveness in treating other cancers, such as advanced non-small-cell lung cancer and cervical cancer, by blocking a protein that helps cancer cells hide from the immune system. This suggests it might also help in treating brain cancer when combined with other treatments.12345
Is the treatment ASP8374 + Cemiplimab generally safe for humans?
Cemiplimab, also known as Libtayo, has been shown to have an acceptable safety profile in clinical trials for various cancers, including advanced cutaneous squamous cell carcinoma and cervical cancer. Most side effects were manageable with appropriate treatment or by stopping the medication, and serious side effects were relatively rare.26789
What makes the drug combination ASP8374 and Cemiplimab unique for treating recurrent brain cancer?
ASP8374 and Cemiplimab is a novel combination for recurrent brain cancer, potentially offering a new approach by combining an immune checkpoint inhibitor (Cemiplimab) with another agent (ASP8374), which may enhance the immune system's ability to fight cancer cells, unlike traditional treatments that often target specific cancer growth pathways.410111213
What is the purpose of this trial?
This trial is testing the safety and effectiveness of combining two drugs, ASP8374 and cemiplimab, for people with recurrent brain cancer. The study aims to find the best dose and see if the combination helps before surgery. The drugs work by boosting the immune system to fight cancer cells. Cemiplimab has been previously tested in combination with other treatments for severe cancers.
Research Team
David A Reardon, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for adults over 18 with recurrent malignant glioma, either WHO grade IV GBM or variants, or grade III (Cohort 1 only). They must have a Karnofsky performance status of ≥70 and show tumor progression. Participants need adequate organ function and should be at their first or second relapse after radiotherapy. Pregnant women and those with certain medical conditions or treatments are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ASP8374 when combined with cemiplimab using a 3+3 design
Dose Expansion
Participants randomized into treatment groups to receive ASP8374 plus cemiplimab prior to surgery or no therapy prior to surgery
Post-operative Treatment
All Cohort 2 participants receive ASP8374 plus cemiplimab every 3 weeks at the MTD/RP2D established by Cohort 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ASP8374
- Cemiplimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Astellas Pharma Inc
Industry Sponsor
Tadaaki Taniguchi
Astellas Pharma Inc
Chief Medical Officer since 2023
MD, PhD
Naoki Okamura
Astellas Pharma Inc
Chief Executive Officer since 2023
University of Tokyo, Faculty of Pharmacy