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

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NCT05731947 · results posted

Sponsored by Syndax Pharmaceuticals (industry) · SNDX — their whole pipeline →.

Phase
Phase 1/2
Status
Terminated
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
41actual
Sites
6
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Why the sponsor stopped it

Study was terminated by sponsor after Phase 1b as pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort.

As filed on the registry record, in the sponsor's own words.

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-04-04actualWhen the study began enrolling
Primary completion2025-06-30actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-06-30actualThe whole study's end, after follow-up
First posted2023-02-16actualWhen this record first appeared on the registry
Results posted2026-07-06actualWhen the sponsor posted results to the registry
Record updated2026-07-06actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Colorectal Cancer
  • Solid Tumors

Interventions

  • Drug: Revumenib — also filed as SNDX-5613
  • Drug: Chemotherapy

Primary outcomes

what the primary-completion date above is the date OF
Phase 1a: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
measured Day 1 up to Day 28
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
measured Up to 2.2 years
Phase 1: Disease Control Rate (DCR)
measured Up to 2.2 years
Phase 1: Overall Response Rate (ORR)
measured Up to 2.2 years
Phase 2: Progression Free Survival (PFS)
measured Up to 2.2 years

Posted documents

hosted by the registry — we link, never re-serve
Study Protocolposted 2024-06-18 · 1.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-04-21 · 1.8 MB · SAP_001.pdf

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