NCT05731947

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

A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNDX-5613 in Patients With Colorectal Cancer and Other Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Syndax Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colorectal Cancer
• Solid Tumors

Interventions

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

Timeline

• Start date: 2023-04-04
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2023-02-16
• Last updated: 2026-01-29

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study