SNDX-5613 for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

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.

+7 more

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.

+11 more

Participant Groups

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.

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.