Trial results for Revumenib in participants with colorectal cancer and other solid tumors were posted on 2026-07-06. The PHASE1/PHASE2 study was ultimately TERMINATED, though Phase 1a data reported 0 Participants experiencing dose-limiting toxicities across all evaluated dose levels.

Background

The study evaluated Revumenib in participants with colorectal cancer (CRC) or other solid tumors who had failed at least one prior line of therapy. The trial aimed to assess the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of the drug.

Trial design

The study, identified as NCT05731947, was a PHASE1/PHASE2 trial that was ultimately TERMINATED. It enrolled 41 participants with colorectal cancer and other solid tumors. The trial evaluated revumenib in various dose formulations and levels.

Key results

Regarding safety, the Number of Participants Experiencing Dose Limiting Toxicities (DLTs) was 0 Participants for all evaluated dose levels in Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule, Revumenib 220 mg Tablet or 226 mg Capsule, and Revumenib 270 mg Tablet or 276 mg Capsule.

The Number of Participants With Treatment-emergent Adverse Events (TEAEs) was reported as 3 Participants for Revumenib 160 mg Tablet or 163 mg Capsule, 8 Participants for Revumenib 220 mg Tablet or 226 mg Capsule, 6 Participants for Revumenib 270 mg Tablet or 276 mg Capsule in Phase 1a, and 22 Participants for Revumenib 270 mg Tablet in Phase 1b.

For efficacy, the Disease Control Rate (DCR) varied across groups. It was 0 percentage of participants (95% Confidence Interval) for Revumenib 160 mg Tablet or 163 mg Capsule, 25.0 percentage of participants (95% Confidence Interval) for Revumenib 220 mg Tablet or 226 mg Capsule, and 33.3 percentage of participants (95% Confidence Interval) for Revumenib 270 mg Tablet or 276 mg Capsule in Phase 1a. In Phase 1b, the DCR for Revumenib 270 mg Tablet was 10.0 percentage of participants (95% Confidence Interval).

The Overall Response Rate (ORR) was 0 percentage of participants (95% Confidence Interval) for Revumenib 160 mg Tablet or 163 mg Capsule.

What this means

The termination of this PHASE1/PHASE2 trial for Revumenib in colorectal cancer and other solid tumors indicates that the study did not proceed as initially planned. Despite the termination, the Phase 1a safety data showed no dose-limiting toxicities across the evaluated dose levels, suggesting a tolerable safety profile in the initial dose escalation. Efficacy results for Disease Control Rate varied, peaking at 33.3% in one Phase 1a arm, while the Overall Response Rate was 0% in the only reported arm. These early findings, coupled with the trial's termination, suggest that further development in this specific indication may not be pursued based on the observed data.

Source

These trial results were posted on ClinicalTrials.gov on 2026-07-06. The full details of the study, NCT05731947, are available on clinicaltrials.gov.