Only 3 spots left

~3 spots leftby Apr 2026

ASP8374 + Cemiplimab for Recurrent Brain Cancer

Recruiting at 3 trial locations

Overseen byDavid A Reardon, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

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

I am using or willing to use effective birth control during and for 4 months after the study.

You are willing and able to read and sign a form that says you agree to participate in the trial.

My condition has worsened for the first or second time after improving.

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Exclusion Criteria

Pregnant, breastfeeding, or expecting to conceive within the projected duration of the trial

You are currently or planning to participate in a study that involves testing a new drug or medical device.

I have an active tuberculosis infection.

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Treatment Details

Interventions

ASP8374 (Monoclonal Antibodies)
Cemiplimab (Monoclonal Antibodies)

Trial OverviewThe study tests the combination of ASP8374 with cemiplimab in two parts: finding the safest high dose (Part 1) and assessing its effect before surgery (Part 2). It aims to establish safety and effectiveness against recurrent brain tumors.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: ASP8374 and Cemiplimab-Cohort 2Experimental Treatment2 Interventions

Upon determination of the MTD/RP2D of ASP8374 plus cemiplimab in Cohort 1, a dose expansion will be performed in which eligible participants who are candidates for surgical resection will enroll to Cohort 2 and will be randomized into one of two treatment groups (2A-2B). Group 2A: IV ASP8374 plus cemiplimab within 14± 5 days prior to surgery at the MTD/RP2D established in Cohort 1. Group 2B: No immune checkpoint therapy prior to surgery. Post-operatively, all Cohort 2 participants will receive ASP8374 plus cemiplimab every 3 weeks administered at the MTD/RP2D established by Cohort 1

Group II: ASP8374 and Cemiplimab-Cohort 1Experimental Treatment2 Interventions

A 3+3 dose escalation design will be used to determine maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ASP8374 when combined with cemiplimab. Participants will receive ASP8374 and Cemiplimab every 3 weeks for up to 2 years. ASP8374 will be available until October 31, 2022. Subjects may continue treatment with cemiplimab alone after that date.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine