A Phase I Study of RLY-4008 for Intrahepatic Cholangiocarcinoma and Other Advanced Solid Tumors

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Full Title

A First-in-human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug RLY-4008 that can be given safely in patients with cancer of the bile duct inside the liver (intrahepatic cholangiocarcinoma or ICC) or other advanced solid tumors with a mutation in a protein called FGFR2. Mutations in FGFR2 are found in some cancers, where they help the cells to grow and spread. RLY-4008 blocks FGFR2, which could cause cancer cells to die and slow or stop the growth of the tumor. RLY-4008 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable ICC or other advanced solid tumor that cannot be successfully treated with standard therapies and contains a mutated or amplified FGFR2 protein.
  • At least 2 weeks must pass between the completion of prior treatment (4 weeks since any regional therapies such as chemoembolization) and receipt of RLY-4008.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alison Schram at 646-888-5388.

Protocol

20-523

Phase

I

Investigator

Co-Investigators