ASP8374 + Cemiplimab in Recurrent Glioma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04826393
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASP8374 — DRUG
    every 3 weeks by intravenous infusion
  • cemiplimab — DRUG
    intravenous infusion

Study Details

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

Key Dates

Start date
Mar 9, 2022
Status verified
Oct 2025
Primary completion
Oct 31, 2022
Completion
Jan 1, 2024

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ASP8374 and Cemiplimab-Cohort 1
    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.
  • Experimental: ASP8374 and Cemiplimab-Cohort 2
    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

Primary Outcome Measure

Maxium Tolerated Dose-MTD/ Phase 2 Recommend Dose-RP2D - Cohort 1 [ Time Frame: Enrollment up to 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-
Columbia University Medical CenterNew YorkNew York10032-
University of Cincinnati Medical CenterCincinnatiOhio45219-
Hospital of the University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19104-

Find similar trials in Boston, MA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Brigham and Women's Hospital· Boston, MAColumbia University Medical Center· New York, NYUniversity of Cincinnati Medical Center· Cincinnati, OHHospital of the University of Pennsylvania, Abramson Cancer Center· Philadelphia, PA

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