The purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype. Study details include: Study Duration per participant: Approximately 4 months
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
M3554 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose is determined in participants with STS (dose escalation A) and glioblastoma and IDH wildtype (dose escalation B).
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMemorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc
New York, New York, United States
Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)
Time frame: up to 4 months
Pharmacokinetic (PK) Plasma Concentrations of M3554
Time frame: Cycle 1 Day 1 to Cycle 3 Day 15 and every second cycle from Cycle 4 (each cycle is of 21 days), assessed up to approximately 4 months
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 as Assessed by Investigator
Time frame: Time from randomization to planned assessment at 4 months
Duration of Response (DoR) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator
Time frame: Time from randomization to planned assessment at 4 months
Progression-free Survival (PFS) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator
Time frame: Time from randomization to planned assessment at 4 months
Change from Baseline in Corrected QT Interval (QTc) Interval
Time frame: Pre-dose on Day 1 (baseline) up to 24 hours post-dose Day 1, Day 2, Day 5, Day 8 of Cycle 1 and Cycle 3 Day 1 (each Cycle is 21 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGInstitut Bergonié - Service d'Oncologie Médicale
Bordeaux, France
RECRUITINGCentre Oscar Lambret - cancerologie generale
Lille, France
RECRUITINGCentre Leon Berard - Service d'Oncologie Medicale
Lyon, France
RECRUITINGCentre Antoine Lacassagne - Service d'Hématologie Oncologie
Nice, France
RECRUITINGNational Cancer Center Hospital
Chūōku, Japan
RECRUITINGUniversitaetsspital Zuerich - Klinik fuer Neurologie
Zurich, Switzerland
RECRUITING...and 1 more locations