TerminatedPhase 1

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

Stopped: Samus Therapeutics Company Closure

United States7 participantsStarted 2021-12-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female subjects having histologically confirmed IDH wildtype glioblastoma (Parts 1 and 2), or grade 3 or 4 IDH mutant astrocytoma (Part 1 only) per WHO criteria * Subjects must be at 1st, 2nd, or 3rd recurrence (Part 1) or 1st or 2nd recurrence (Part 2) and with at least 5 subjects clinically requiring reoperation for tumor progression (Part 2). ; Note: recurrence is defined as progression following initial therapy (i.e., radiation, chemotherapy, or radiation + chemotherapy); if the participant had a surgical resection for relapsed disease and no anti-tumor therapy instituted for up to 12 weeks, this is considered one recurrence. * Measurable disease as defined by modified RANO (1 cm × 1 cm minimum dimensions, at least 12 weeks after final radiotherapy dose; if new disease is outside radiotherapy field, \<4 weeks is acceptable). * Cranial MRI performed within 14 days prior to study entry. * Age equal to or greater than 18 years * Karnofsky performance status of \>60 at screening * Adequate bone marrow, liver and renal functions (tests must be performed within 14 days prior to enrollment).The following laboratory values must be documented within 3 days prior to the first dose of study drug Absolute neutrophil count (ANC) ≥1.5 × 109/L Platelet count ≥100 × 109/L Estimated creatinine clearance (CrCl) \>60 mL/min by Cockcroft-Gault formulation Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × the upper limit of normal (ULN) …

What they're measuring

Incidence and severity of adverse events

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Maximum Tolerated Dose (MTD)/Coverage with evidence development (CED)/recommended phase 2 dose (RP2D) (Part 1 Only

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Icapamespib Plasma Concentration at Time of Surgery

Timeframe: 7-14 days post surgery

Trial details

NCT IDNCT04782609

SponsorSamus Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-04

View on ClinicalTrials.gov More Recurrent Glioblastoma Multiforme (GBM) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence and severity of adverse events

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Maximum Tolerated Dose (MTD)/Coverage with evidence development (CED)/recommended phase 2 dose (RP2D) (Part 1 Only

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Icapamespib Plasma Concentration at Time of Surgery

Timeframe: 7-14 days post surgery