Clinical trialNCT03597581CompletedPhase 1Interventional

A Study of RGX-202-01 (Ompenaclid) as Combination Therapy in RAS Mutant Advanced Colorectal Cancer

SponsorInspirna, Inc.Enrollment89CRCColorectal CancerColorectal Cancer MetastaticColorectal CarcinomaColorectal NeoplasmsGastric Cancer+4 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a Phase 1 study currently evaluating PO administered ompenaclid in combination with FOLFIRI and bevacizumab in patients with advanced (i.e., locally advanced and unresectable, or metastatic) previously treated colorectal adenocarcinoma. The single agent ompenaclid dose escalation stage and the ompenaclid in combination with FOLFIRI and bevacizumab dose escalation stage of the study has been completed; the expansion stage of ompenaclid in combination with FOLFIRI and bevacizumab is ongoing. In April-24 a protocol amendment added a new dose escalation and expansion stage which will evaluate ompenaclid in combination with FOLFOX and bevacizumab in patients with metastatic CRC. It is anticipated that a total of 30 patients will be enrolled in this new dose escalation and expansion stage of the study.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Robert Wasserman, MD
CMO
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

17 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Arizona Oncology Associates, Pc - Hal
Prescott Valley, Arizona, United States
Arizona Oncology Associates, Pc - Hop E
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Sharp Healthcare
San Diego, California, United States
Sansum Clinic
Santa Barbara, California, United States
Ucla Department of Medicine
Santa Monica, California, United States
Medical Oncology Hematology Consultants, Pa
Newark, Delaware, United States
Oncology Hematology West P.C. Dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Dartmouth
Lebanon, New Hampshire, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Thomas Jefferson
Philadelphia, Pennsylvania, United States
Prisma Health Cancer Institute
Greenville, South Carolina, United States
Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology, P.A
McAllen, Texas, United States
Texas Oncology, P.A
Tyler, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Bevacizumab →FOLFIRI Regimen →FOLFOX regimenOmpenaclid

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 5 Jun 2018
Primary completion: 31 Mar 2025
Completion: 31 Mar 2025
Last update posted: 3 Apr 2025
Registered enrollment: 89
Registry id: NCT03597581

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.