A Phase I Study of RGX-202-01 with or without FOLFIRI in Patients with Advanced Digestive Cancers

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Full Title

A Phase 1 Study of RGX-202-01, a Small Molecule Inhibitor of the Creatine Transporter, SLC6a8, with or without FOLFIRI in Patients with Advanced Gastrointestinal Malignancies with Select Expansion Cohorts

Purpose

The purpose of this study is to find the highest dose of the investigational drug RGX-202-01 that can be given alone and in combination with FOLFIRI chemotherapy in patients with advanced digestive cancers that cannot be cured with standard therapies. RGX-202-01 blocks a pathway called SLC6a8 that cancer cells use to get energy to grow and spread. RGX-202-01 has slowed the growth and/or shrunk several types of digestive cancers in laboratory studies.

FOLFIRI is a regimen of chemotherapy drugs (irinotecan, 5-fluorouracil, and folinic acid) used to treat some kinds of stomach and colorectal cancers. In this study, patients will receive either RGX-202-01 alone or with FOLFIRI. RGX-202-01 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 an advanced digestive cancer that cannot be cured with standard therapies. Examples include stomach, gastroesophageal junction, pancreatic, biliary, small intestine, and colorectal cancers.
  • At least 2 weeks must pass between the completion of prior treatment and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Andrea Cercek at 646-888-4189.

Protocol

19-047

Phase

I

Investigator

Co-Investigators