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Trials / Terminated

TerminatedNCT04782609

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

A Phase 1b Dose Escalation/Dose Expansion Study of Icapamespib (PU-AD) in Patients With Recurrent Malignant Glioma

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
7 (actual)
Sponsor
Samus Therapeutics, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

This is a 2-part multicenter Phase 1b study designed to test the safety, tolerability and pharmacokinetics of single agent oral 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. The RP2D may be the same as the maximum tolerated dose (MTD) or modified from the MTD based on assessment of overall exposure, safety experience in Cycle 2 and beyond, and clinical benefit data in the study. The RP2D will be determined in the dose expansion phase of the study. Part 1: Up to 30 patients with 1st, 2nd or 3rd recurrence of IDH wild type glioblastoma multiforme (GBM) or grade 3 or 4, Isocitrate dehydrogenase (IDH) mutant astrocytoma will be enrolled to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and MTD of single agent oral icapamespib administered daily. Icapamespib will be administered orally once daily for each 28-day cycle. The initial dose in this trial will be 20 mg in Cohort 1. Dose escalation will proceed as follows: * 100% increment until the first drug-related Grade 2 adverse event (AE) occurs, then * 50% increment until the first drug-related Grade 3 event occurs, then * 33% increment until the first Dose Limiting Toxicities (DLT) occurs, then * 20% increment until RP2D is declared.

Conditions

Interventions

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

Timeline

Start date
2021-12-27
Primary completion
2022-11-04
Completion
2022-11-04
First posted
2021-03-04
Last updated
2022-11-17

Locations

5 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04782609. Inclusion in this directory is not an endorsement.