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Study of Icapamespib (PU-AD) in Patients With Recurrent Malignant Glioma

NCT04782609 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-11-17

No results posted yet for this study

Summary

This is a 2-part multicenter Phase 1b study designed to test icapamespib in patients with recurrent brain lesions.

Part 1 of the trial will be a standard 3 by 3 dose escalation design where different doses are examined. Part 2 will be a dose expansion cohort to further evaluate the recommended Phase 2 dose (RP2D). The RP2D is defined as the dose level recommended for further clinical study, or the highest dose tested.

Conditions

  • Recurrent Glioblastoma Multiforme (GBM)
  • Grade 3 Isocitrate Dehydrogenase (IDH) Wildtype Astrocytoma
  • Grade 3 or 4 Astrocytoma
  • Glioblastoma Surgery

Interventions

DRUG

Icapamespib

to test the safety, tolerability and pharmacokinetics of single agent oral icapamespib in patients with recurrent brain lesions.

Sponsors & Collaborators

  • Samus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Silverman, MD · Samus Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-27
Primary Completion
2022-11-04
Completion
2022-11-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04782609 on ClinicalTrials.gov