Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Syndax Pharmaceuticals
Study ID
NCT05731947
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Revumenib — DRUG
    Revumenib administered orally with or without food. Participants may continue to receive treatment until disease progression or until they experience unacceptable toxicity.
  • Chemotherapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 4, 2023
Status verified
Jan 2026
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
42 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a: Dose Escalation
    Participants will receive revumenib tablets or capsules three times a day (TID) or two times a day (BID) from Day 1 of each 28-day cycle.
  • Experimental: Phase 1b: Signal-Seeking
    Participants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle.
  • Experimental: Phase 2: Revumenib
    Participants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle.
  • Active Comparator: Phase 2: Chemotherapy
    Participants will receive chemotherapy from Day 1 of each 28-day cycle.

Primary Outcome Measure

Phase 1a: Number of Participants Experiencing Dose Limiting Toxicities [ Time Frame: Up to Day 29 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85258-
Massachusetts General HospitalBostonMassachusetts02114-
Memorial Sloan Kettering Cancer CenterManhattanNew York10065-
Gabrail Cancer CenterCantonOhio44718-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Inova Schar Cancer InstituteFairfaxVirginia22031-

Find similar trials in Scottsdale, AZ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Honor Health Research Institute· Scottsdale, AZMassachusetts General Hospital· Boston, MAMemorial Sloan Kettering Cancer Center· Manhattan, NYGabrail Cancer Center· Canton, OHVanderbilt-Ingram Cancer Center· Nashville, TNInova Schar Cancer Institute· Fairfax, VA

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