A Phase 1/2 Study of AMG 193 Plus IDE397 to Treat Advanced Digestive Cancers Lacking the MTAP Protein

Full Title

A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors

Purpose

Researchers want to find the best doses of two new drugs to treat digestive cancers. The drugs are AMG 193 (called a PRMT5 inhibitor) and IDE397 (an MAT2A inhibitor). In this study, they are being given together.

The people in this study have advanced digestive cancer with loss of the MTAP gene. This mutation leads to a loss of the MTAP protein.

Both AMG 193 and IDE397 block proteins that play a role in cancer growth and survival. AMG 193 may be especially helpful for people with cancers that lack the MTAP protein. AMG 193 and IDE397 are taken orally (by mouth).

Who Can Join

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

• Have an advanced digestive cancer that lacks the MTAP protein.
• Have completed prior anti-cancer medications at least 4 weeks before getting the study drugs.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Wungki Park’s office at 646-888-4543.