Ompenaclid (RGX-202) is an oral small molecule inhibitor of SLC6A8 that induces apoptosis (cell death) of colorectal cancer cells that is currently being tested in combination with the standard-of-care regimen FOLFIRI and bevacizumab in a Phase 1b clinical trial for the 2nd line treatment of patients with advanced colorectal cancer whose tumors express mutations in the RAS gene (~40-45% of colorectal cancers).
1. What are the main criteria for eligibility?
- Have colorectal adenocarcinoma that is actively growing despite treatment.
- Received only one prior therapeutic regimen that included oxaliplatin.
- Never have been treated with irinotecan.
- Must have a tumor that is laboratory-confirmed to be RAS mutated.
2. What if I originally had the cancer removed by surgery and then was treated with (adjuvant) chemotherapy?
You are eligible if you developed recurrent metastatic colorectal cancer within 12 months of completion of adjuvant oxaliplatin and 5-FU based therapy, and did not receive additional therapy after the recurrence.
3. What if I have dMMR/MSI-H colorectal cancer?
If you have dMMR/MSI-H colorectal cancer, you must have received prior treatment with KEYTRUDA (pembrolizumab) or an FDA approved PD-1/L1 inhibitor in addition to a therapeutic regimen that included oxaliplatin to be eligible.
4. Why are patients who previously received irinotecan ineligible?
Our selected 2nd-line treatment is FOLFIRI which contains irinotecan. Patients whose disease worsen after being exposed previously to irinotecan containing regimens (such as FOLFIRI or FOLFOXIRI) may be resistant to irinotecan and therefore are not eligible to enter the study.
5. Are any other first-line treatments allowed for me to be eligible?
Since oxaliplatin is the backbone of first-line regimens in colorectal cancer, patients must have previously received it to be eligible. However, as long as the patient hasn’t received irinotecan, most other standard chemotherapies given in first-line will be allowed for eligibility, such as 5-FU and capecitabine.
6. Is there reimbursement for travel expenses for participation in the trial?
Yes. We will reimburse some travel expenses such as hotel accommodations for patients arriving from a distance to the research sites. We can determine what expenses to cover based on each patient’s situation.
7. Who can I contact to ask additional questions about the therapy?
- For further inquiries about the therapy or clinical trial, please contact us at this email address: [email protected] or to find out more about Inspirna, please email: [email protected]
- You can also contact individual site investigators conducting the trial. Contact information can be found at: https://clinicaltrials.gov/ct2/show/NCT03597581?term=RGX-202&draw=2&rank=1
8. Where can a patient go to be treated on the clinical trial?
- The active trial sites with the investigator and contact information can be found at: https://clinicaltrials.gov/ct2/show/NCT03597581?term=RGX-202&draw=2&rank=1
- In addition, if none of the sites are within a reasonable distance for you, we may be able to treat you at closer site through the Tempus network. Please contact us at [email protected] to explore options.
9. Are you considering expanding to allow patients that have had a second-line and later lines of therapy?
We are currently focused on patients that need second-line therapy. However, we have interest in potentially conducting clinical trials in later lines of therapy in the future, and are also generating data in the laboratory with other agents combined with ompenaclid (RGX-202) to select the best combination for use in later lines.
10. Is ompenaclid (RGX-202) available on expanded access/compassionate use outside of the trial? If not, any plans on making it available in this fashion?
Unfortunately, ompenaclid (RGX-202) is not currently available on expanded access or compassionate use. However, as we generate more clinical data to confirm our findings and select the optimal dose to move forward, as per feedback from the FDA, we will continue to consider our options to enroll more patients in need into our clinical study.