RGX-202-01 With or Without FOLFIRI in Advanced Gastrointestinal Malignancies

What is the Purpose of this Study?

This study focuses on patients who have an advanced cancer for which further treatment is recommended, but standard (non-research) treatment is no longer effective. The study will evaluate an investigational drug called RGX-202-01. It is hoped that by taking RGX-202-01, alone or in combination with a chemotherapy regimen called FOLFIRI (chemotherapy drugs approved by the U.S. Food and Drug Administration), the growth of the patient’s tumor will be slowed or will shrink.

The study has two parts; patients may be enrolled in either the first or second part of the study. The purpose of the first part is to determine the highest tolerable dose of RGX-202-01 alone and in combination with FOLFIRI. The second part will evaluate whether RGX-202-01 alone or RGX-202-01 combined with FOLFIRI might be effective treatment options for individuals with advanced cancers, using the highest tolerable dose of RGX-202-01 determined in the first part. Researchers also aim to understand the safety and side effects of RGX-202-01, as well as how the drug moves through the body (pharmacokinetics) and affects various types of cells in the blood and cancer (pharmacodynamics).


Eligibility

  • * The patient must have histologic or cytologic evidence of a RAS colorectal cancer of adenocarcinoma or poorly differentiated histology and must have disease that is resistant to or relapsed following available standard systemic therapy or for which there is no standard systemic therapy or reasonable therapy likely to result in clinical benefit or if such therapy has been refused by the patient.
  • * The patient must have advanced disease, defined as cancer that is either metastatic or locally advanced and unresectable (and for which additional radiation therapy or other locoregional therapies are not considered feasible).
  • * Pathologically documented adenocarcinoma or poorly differentiated locally advanced/metastatic colorectal cancer
  • * Have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator
Show more

Where can I participate?

Cedars-Sinai Cancer at SOCC

More about this Clinical Trial

What is the full name of this clinical trial?

RGX-202-001: 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

Study Details
Disease Type/Condition

Anus, Colon, Esophagus, Other Digestive Organ, Pancreas, Prostate, Rectum, Small Intestine, Stomach

Principal Investigator

Hendifar, Andrew

Co-Investigators

Alain Mita, Jun Gong, Kamya Sankar, Kevin Scher

Age Group

Adult

Phase

I

IRB Number

Pro00055176

ClinicalTrials.gov ID

NCT03597581

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Anus, Colon, Esophagus, Other Digestive Organ, Pancreas, Prostate, Rectum, Small Intestine, Stomach

Principal Investigator

Hendifar, Andrew

Age Group

Adult

Phase

I

IRB Number

RGX-202-001

ClinicalTrials.gov ID

NCT03597581

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org