A Phase 1 Study of SNDX-5613 in People With Advanced Colorectal Cancer and Other Digestive Tumors


Full Title

A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNDX-5613 in Patients with Colorectal Cancer and Other Solid Tumors


Researchers are assessing the safety and effectiveness of SNDX-5613 in people with colorectal cancer and other digestive cancers. The people in this study have colorectal cancer or another cancer of the digestive tract. Their cancers have metastasized (spread) and are inoperable (cannot be taken out with surgery). In addition, the cancer keeps growing even after treatment with chemotherapy.

SNDX-5613 prevents the binding of a protein called menin to another protein called KMT2A (MLL1). Blocking this binding may slow cancer growth. SNDX-5613 is taken orally (by mouth) three times a day.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have colorectal cancer or another digestive cancer that is inoperable and metastatic. The cancer must keep growing even though you had treatment with chemotherapy.
  • Have recovered from the serious side effects of prior treatments before taking SNDX-5613.
  • Be well enough to walk and take care of yourself. You must be able to do physical activities such as office work or light housework.
  • Be of age 18 years or older.


For more information or to see if you can join this study, please call Dr. Maliha Nusrat’s office at 646-888-6872.




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID