This study will evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of revumenib in participants with colorectal cancer (CRC) or other solid tumors who have failed at least 1 prior line of therapy.
The study will be conducted in two parts. The Phase 1 portion of the study consists of a dose escalation cohort, and a signal-seeking expansion where anti-tumor activity signals will be evaluated. The Phase 2 portion of the study will further confirm the anti-tumor activity signals of revumenib.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Revumenib administered orally with or without food. Participants may continue to receive treatment until disease progression or until they experience unacceptable toxicity.
Either Lonsurf® or Stivarga® administered per the investigator's choice at the respective drug label's dose and schedule. Participants may continue to receive treatment until disease progression or until they experience unacceptable toxicity.
Honor Health Research Institute
Scottsdale, Arizona, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
Manhattan, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
Phase 1a: Number of Participants Experiencing Dose Limiting Toxicities
Time frame: Up to Day 29
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Approximately 12 months
Phase 1b: Disease Control Rate (DCR)
Time frame: Approximately 6 months
Phase 1b: Overall Response Rate (ORR)
Time frame: Approximately 6 months
Phase 2: Progression Free Survival (PFS)
Time frame: Approximately 4 months
Phase 1: Maximum Plasma Concentration (Cmax) of Revumenib
Time frame: Predose up to approximately 12 months
Phase 1: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Time frame: Predose up to approximately 12 months
Phase 1: Area Under the Plasma Concentration Versus Time Curve (AUC) of Revumenib
Time frame: Predose up to approximately 12 months
Phase 2: AUC of Revumenib
Time frame: Predose up to approximately 6 months
Phase 2: Cmax of Revumenib
Time frame: Predose up to approximately 6 months
Phase 2: Tmax of Revumenib
Time frame: Predose up to approximately 6 months
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Phase 2: Number of Participants Experiencing TEAEs
Time frame: Approximately 3 years
Phase 2: Overall Survival (OS)
Time frame: Approximately 5 years
Phase 2: DCR at 6 Cycles (28-Day Cycles) as Assessed by Blinded Radiographic Review
Time frame: Approximately 6 months
Phase 2: ORR as Assessed by Blinded Radiographic Review Using Response Evaluation Criteria in Solid Tumors (RECIST), version (v)1.1
Time frame: Approximately 6 months
Phase 2: Duration of Response (DOR) as Assessed by Blinded Radiographic Review
Time frame: Approximately 3 years
Phase 2: DCR at 6 Cycles (28-Day Cycles) as Assessed by the Investigator
Time frame: Approximately 6 months
Phase 2: ORR as Assessed by the Investigator per RECIST v1.1
Time frame: Approximately 6 months
Phase 2: DOR as Assessed by the Investigator
Time frame: Approximately 3 years