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Epigenetic Modulator

SNDX-5613 for Colorectal Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Syndax Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new drug for people with colorectal cancer or solid tumors who have already tried other treatments.

Who is the study for?
Adults over 18 with colorectal or other solid tumors that have worsened after treatment, or who couldn't tolerate standard therapies including oxaliplatin, irinotecan, and bevacizumab. They must not have active infections like hepatitis B/C or HIV, serious heart conditions in the past 6 months, certain GI issues affecting drug absorption, brain metastasis requiring steroids, or any condition that might interfere with study participation.
What is being tested?
The trial is testing SNDX-5613 combined with chemotherapy to see how safe it is and how well it works against colorectal cancer and other solid tumors in patients who've already tried at least one line of therapy without success.
What are the potential side effects?
Possible side effects include typical reactions to chemotherapy such as nausea, fatigue, hair loss; specific side effects related to SNDX-5613 are being studied but may involve changes in blood counts leading to increased infection risk or bleeding problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2: RevumenibExperimental Treatment1 Intervention
Participants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle.
Group II: Phase 1b: Signal-SeekingExperimental Treatment1 Intervention
Participants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle.
Group III: Phase 1a: Dose EscalationExperimental Treatment1 Intervention
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.
Group IV: Phase 2: ChemotherapyActive Control1 Intervention
Participants will receive chemotherapy from Day 1 of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Revumenib
2022
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor
48 Previous Clinical Trials
2,652 Total Patients Enrolled

Media Library

SNDX-5613 (Epigenetic Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05731947 — Phase 1 & 2
~59 spots leftby Dec 2025
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