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ASP8374 + Cemiplimab in Recurrent Glioma

NCT04826393 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-10-22

No results posted yet for this study

Summary

This study is looking at the safety and efficacy of the drug combination of ASP8374 with cemiplimab in people with recurrent malignant glioma.

The study will be conducted in two parts, the first portion of the study will be to establish the highest dose of ASP8374 that can be given safely with cemiplimab and will be used as the recommended dose of ASP8374 in combination with cemiplimab for the second portion of the study. The second portion of the study will be to compare the effect of having ASP8374 in combination with cemiplimab prior to surgery.

The names of the study drugs involved in this study are:

* ASP8374
* Cemiplimab

Conditions

Interventions

DRUG

ASP8374

every 3 weeks by intravenous infusion

DRUG

cemiplimab

intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • David A Reardon, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2022-10-31
Completion
2024-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04826393 on ClinicalTrials.gov