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

Completed · Phase 1

Conditions studied: Gastrointestinal Cancer, Gastrointestinal Neoplasms, Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Gastric Cancer, Gastric Neoplasm, KRAS Mutation-Related Tumors, CRC, Colorectal Cancer Metastatic

In brief

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.

Key facts

Study ID

NCT03597581

Run by

Inspirna, Inc.

People needed

89

Starts

2018-06-05

Expected to finish

2025-03-31

Last updated by the study team

2025-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Adults ≥18 years
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
• Adequate cardiac function, as defined by left ventricular ejection fraction (LVEF) ≥45%
• Adequate organ function
• Prothrombin time ≤1.5 x ULN or international normalized ratio within ≤1.5; and either partial thromboplastin time or activated partial thromboplastin time ≤1.5 x ULN. Patients on warfarin may be included if on a stable dose with a therapeutic INR <3.5
• Inclusion Criteria for RGX-202-01 plus FOLFIRI and bevacizumab expansion stages:
• For the expansion stage only, patients must have a tumor that is laboratory-confirmed to be RAS mutant.
• Must have received only one prior standard of care oxaliplatin-containing regimen for locally advanced/metastatic colorectal cancer (CRC)
• Must have received prior treatment with pembrolizumab or an FDA approved PD-1/L1 inhibitor as well, if the patient has dMMR/MSI-H colorectal cancer
• May have received prior treatment with bevacizumab, cetuximab, or panitumumab, or an FDA approved biosimilar.
• Exclusion Criteria for RGX-202-01 plus FOLFIRI and bevacizumab expansion stages:
• Unresolved Grade > 2 toxicities from prior anticancer therapy; excluding Grade 2 chemotherapy-related neuropathy, alopecia; and excluding Grade 2-3 asymptomatic laboratory abnormalities if considered clinically insignificant by the Investigator, or can be managed with available medical therapies
• Has malignancy of small cell, neuroendocrine, or squamous histology
• Unable to meet the requirement of an adequate treatment washout period before enrollment
• Has additional malignancy that may confound the assessment of study endpoints. Participants with non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia, and melanoma in situ), organ-confined prostate cancer with no evidence of progressive disease are not excluded
• Has clinically significant cardiovascular disease (New York Heart Association Class III or IV congestive heart failure, history of myocardial infarction, uncontrolled angina, unstable angina or stroke within 6 months before enrollment, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication
• Has clinically active brain or leptomeningeal metastases
• Has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or breast feeding
• Has an ongoing chronic hepatopathy of any origin
• Has an evidence of muscular dystrophies or ongoing muscle pathology

Where it is running

• 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

Full record on ClinicalTrials.gov

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