SNDX-5613 for Colorectal Cancer

Recruiting at 5 trial locations

Overseen By Syndax Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Syndax Pharmaceuticals

Disqualifiers: HIV, Hepatitis B/C, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

42 Participants Needed

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, there are specific washout periods for certain treatments, such as a 2-week period after radiation therapy and 42 days after immunotherapy. It's best to discuss your current medications with the trial team.

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Participants receive revumenib tablets or capsules TID or BID from Day 1 of each 28-day cycle to determine the maximum tolerated dose

28-day cycles

Phase 1: Signal-Seeking

Participants receive revumenib tablets TID or BID from Day 1 of each 28-day cycle to evaluate anti-tumor activity signals

28-day cycles

Phase 2: Treatment

Participants receive either revumenib or chemotherapy from Day 1 of each 28-day cycle to confirm anti-tumor activity signals

28-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SNDX-5613

Trial Overview 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.

Participant Groups

Group I: Phase 2: Revumenib Experimental Treatment 1 Intervention

Participants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle.

Group II: Phase 1b: Signal-Seeking Experimental Treatment 1 Intervention

Participants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle.

Group III: Phase 1a: Dose Escalation Experimental Treatment 1 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: Chemotherapy Active Control 1 Intervention

Participants will receive chemotherapy from Day 1 of each 28-day cycle.

Who Is Running the Clinical Trial?

Syndax Pharmaceuticals

Lead Sponsor

Trials

49

Recruited

2,700+