SNDX-5613 for Colorectal Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness and safety of a drug called revumenib (SNDX-5613) for people with colorectal cancer or other solid tumors. Researchers seek to determine how well this treatment works and identify any side effects. The trial includes different groups: some will receive revumenib, while others will continue with chemotherapy. It seeks participants with metastatic colorectal cancer who have tried at least one standard treatment without a good response. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that SNDX-5613, also known as revumenib, has been tested for safety in people with leukemia. One study involved 135 patients, including 104 adults and 31 children, who received revumenib. The treatment was generally well-tolerated, with most participants not experiencing serious issues.

Although specific details about side effects in this trial are not available, the FDA has approved revumenib for certain types of leukemia, indicating it has met important safety standards for that disease. In ongoing trials for colorectal cancer and other solid tumors, researchers continue to closely monitor its safety for those conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colorectal cancer?

Researchers are excited about SNDX-5613 because it targets a specific protein involved in cancer cell growth, making it different from standard chemotherapy options for colorectal cancer. Most current treatments rely on broad-spectrum chemotherapy, which attacks rapidly dividing cells indiscriminately. SNDX-5613, on the other hand, works by inhibiting the Menin-MLL1 protein-protein interaction, which is a more targeted approach. This specificity has the potential to reduce damage to healthy cells and minimize side effects, offering a promising new avenue for treatment.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research has shown that revumenib, one of the treatments under study in this trial, may help treat colorectal cancer (CRC). Early results suggest it can slow the disease in patients with advanced CRC who have tried other treatments. In a recent study, 68% of patients lived for at least six months after starting revumenib. Importantly, patients tolerated the treatment well, with no serious side effects reported. These findings provide early evidence that revumenib might be effective in managing CRC. Participants in this trial will receive either revumenib or chemotherapy, allowing for a comparison of their effectiveness. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

My cancer has worsened or I had severe side effects from previous treatments.

I have colorectal cancer and treatments like oxaliplatin, irinotecan, and bevacizumab didn't work for me.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05731947

Study Details | NCT05731947 | Evaluation of Revumenib in ... This study will evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of revumenib in participants with colorectal cancer (CRC) or ...

2. ir.syndax.com ir.syndax.com/news-releases/news-release-details/syndax-announces-plans-advance-phase-1b-portion-trial-evaluating

Press Release Details - Investors - Syndax No Grade 3 or greater treatment-related adverse events (TRAEs) were observed and the most common TRAEs were decreased appetite, dysgeusia, ...

3. clin.larvol.com clin.larvol.com/trial-detail/NCT05731947

Evaluation of Revumenib in Participants With Colorectal ... The initial efficacy results provide early clinical support that revumenib may be able to impact disease progression in R/R patients with metastatic MSS CRC.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.3_suppl.TPS227

Phase 1/2 evaluation of revumenib in patients with ... This phase 1/2 study is evaluating revumenib in adults aged ≥18 years with locally recurrent or metastatic CRC who have failed ≥1 prior line of therapy.

5. ir.syndax.com ir.syndax.com/news-releases/news-release-details/syndax-presents-positive-revuforjr-revumenib-data-acute

Syndax Presents Positive Revuforj® (revumenib) Data in ... With a median follow-up of 9.3 months (N=33), the 6-month overall survival (OS) was 68% (95% CI: 47%, 80%); median OS was not reached. The median duration of CR ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/218944s000lbl.pdf

Revuforj (Revumenib) Tablets, for Oral Use - accessdata.fda.gov The safety of REVUFORJ reflects exposure in 135 patients (104 adult and 31 pediatric patients) with relapsed or refractory (R/R) acute leukemia with KMT2A ...

7. ecancer.org ecancer.org/en/news/27195-fda-approves-revumenib-for-relapsed-or-refractory-acute-myeloid-leukaemia-with-a-susceptible-npm1-mutation

FDA approves revumenib for relapsed or refractory acute ... On October 24, 2025, the Food and Drug Administration approved revumenib a menin inhibitor, for relapsed or refractory acute myeloid ...