A Phase 1b Study of AMG 193 Plus mFOLFIRINOX or With Gemcitabine and Nab-paclitaxel in People With Advanced Pancreatic Cancer

Full Title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination with Other Therapies in Subjects with Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers with Homozygous MTAP-deletion

Purpose

Researchers want to learn if AMG 193 in combination with standard treatment is safe for people with advanced pancreatic cancer. The people in this study have pancreatic ductal adenocarcinoma (PDAC) that has metastasized (spread). In addition, their cancers have a mutation (change) in the MTAP gene. This results in a lack of the MTAP protein, which may help cancer grow.

In this study, researchers will find the best dose of AMG 193 for further testing. If you join this study, you will get one of these treatments:

• AMG 193 + gemcitabine + nab-paclitaxel
• AMG 193 + mFOLFIRINOX

AMG 193 is taken orally (by mouth) and the other medications are given intravenously (by vein).

Who Can Join

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

• Have metastatic PDAC and not have received anti-cancer medications for advanced disease.
• Have PDAC that lacks MTAP.
• 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. Eileen O’Reilly’s office at 646-888-4182.