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OMP-21M18 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Open-label OMP-21M18 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| OMP-21M18 | DRUG | The first 6 participants will receive OMP21M18 2.5 mg/kg once every other week, the next 6 participants will receive 5 mg/kg once every other week, and the final 6 participants will receive 10 mg/kg once every other week. A Data Safety Monitoring Board (DSMB) will review the data for the 6 participants in each dose level after the last participant in that group has been treated for 56 days and decide whether it is safe to move up to the next highest dose level. After confirming the optimum dose, 14 additional participants will be treated at the highest dose level that the DSMB considers safe. |
Inclusion criteria 1. Subjects must have histologically confirmed metastatic colorectal cancer. Subjects may not have received more than 1 prior chemotherapy regimen for their metastatic disease and may not have received irinotecan for treatment of their metastatic disease. 2. Age \>21 years 3. ECO...
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OMP-21M18 is an investigational small molecule being developed for the treatment of solid tumors and colorectal cancer. It has been studied in patients with advanced solid tumors and in those with metastatic colorectal cancer. The drug is not approved and remains in clinical development.
OMP-21M18 is being developed by Mereo BioPharma Group plc, a biopharmaceutical company listed on the stock exchange under the ticker MREO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational oncology drug.
OMP-21M18 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in solid tumors and one in metastatic colorectal cancer. The drug is investigational and has not received FDA approval.
OMP-21M18 has been studied in two completed Phase 1 trials. NCT00744562 was a dose escalation study in 42 patients with solid tumors in the United States. NCT01189942 evaluated OMP-21M18 combined with FOLFIRI in 18 patients with metastatic colorectal cancer in Australia and New Zealand.
OMP-21M18 is a small molecule being studied in biomarker-selected patient populations. The clinical trials enrolled patients with solid tumors and colorectal cancer, and the development program includes biomarker selection, indicating a focus on patients whose tumors may express specific molecular characteristics.