A Study of RGX-202-01 (Ompenaclid) as Combination Therapy in RAS Mutant Advanced Colorectal Cancer
Summary
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.
Timeline
- Start
- 2018-06-05
- Primary completion
- 2025-03-31
- Completion
- 2025-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ompenaclid | Small molecule | 1800 mg | Oral |
| Subject | Ompenaclid | Small molecule | 2400 mg | Oral |
| Subject | Ompenaclid | Small molecule | 3000 mg | Oral |
| Background | Bevacizumab | Monoclonal antibody | 5 mg/kg | — |
| Background | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Levoleucovorin | Unknown | 200 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |