SNDX-5613 for Colorectal Cancer
Recruiting at 5 trial locations
SB
LA
SP
SP
Overseen BySyndax Pharmaceuticals
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Syndax Pharmaceuticals
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
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.Inclusion Criteria
My heart, liver, kidneys, and bone marrow are functioning well.
I am 18 years old or older.
My cancer has worsened or I had severe side effects from previous treatments.
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Exclusion Criteria
I haven't had blood products or colony stimulating factors in the last 4 weeks.
I haven't had cancer in the last 5 years, except for specific non-aggressive types.
My liver disease is severe, with a Child-Pugh score of B or C.
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Treatment Details
Interventions
- SNDX-5613 (Epigenetic Modulator)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Syndax Pharmaceuticals
Lead Sponsor
Trials
49
Recruited
2,700+