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OMP-131R10 · 1 trial · 2 indications
Subject will be assessed for DLTs during the evaluation window (28 days). Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined.
| Arm | Type | Description |
|---|---|---|
| OMP-131R10 intravenous (in the vein) infusions | EXPERIMENTAL | OMP-131R10 will be administered IV on the first day of each 14-day cycle. |
| FOLFIRI (5-FU, irinotecan, leucovorin). | EXPERIMENTAL | dosing continues up to the 20 mg/kg dose level |
| Name | Type | Description |
|---|---|---|
| OMP-131R10 | DRUG | There are 5 planned dose cohorts of OMP-131R10. Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity. |
| FOLFIRI | DRUG | Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen. |
Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for the study: 1. Phase 1a portion: Histologically confirmed advanced relapsed or refractory solid tumors that have exhausted standard of care therapy or either refuse or are not considered to be candidates for any...
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OMP-131R10 is an investigational small molecule being studied for the treatment of advanced relapsed tumors and refractory solid tumors. It is being developed by Mereo BioPharma Group plc and has been evaluated in a Phase 1 clinical trial in adult patients with these advanced cancers.
OMP-131R10 is being developed by Mereo BioPharma Group plc, a biopharmaceutical company whose shares trade under the ticker MREO. The company is responsible for the clinical development of this small molecule oncology candidate.
OMP-131R10 is in Phase 1 clinical development. It has completed one Phase 1a/b dose escalation study in patients with advanced relapsed tumors and refractory solid tumors. It is an investigational agent and has not been approved by the FDA.
OMP-131R10 has been evaluated in one completed Phase 1a/b clinical trial, NCT02482441, titled a Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10. The trial enrolled 50 patients with advanced relapsed tumors and refractory solid tumors in the United States.
No, OMP-131R10 is not FDA approved. It is an investigational small molecule in Phase 1 clinical development for advanced relapsed tumors and refractory solid tumors. It has completed one Phase 1a/b trial and remains under clinical evaluation by Mereo BioPharma Group plc.