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Also known as Demcizumab
OMP-21M18 · 7 trials · 6 indications
Investigator assessed Kaplan-Meier estimates of progression-free survival for placebo/placebo arm and pooled demcizumab arm.
Investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 response rate (unconfirmed) in placebo/placebo arm to demcizumab/placebo arm and demcizumab/demcizumab arm combined in subjects with first-line stage IV non-small cell lung cancer (NSCLC). Response rate was based on Investigator-assessed best-overall-response (BOR) and was defined as the best unconfirmed response determined by RECIST version 1.1 recorded from the start of the treatment until disease progression in the following order of importance: CR, PR , SD, progressive disease (PD), not evaluable, or missing.
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with demcizumab in combination with pembrolizumab
| Arm | Type | Description |
|---|---|---|
| Abraxane® and gemcitabine plus placebo | EXPERIMENTAL | Abraxane® and gemcitabine plus placebo (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression |
| Abraxane® and gemcitabine plus demcizumab plus placebo | EXPERIMENTAL | Abraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression |
| Abraxane® and gemcitabine plus demcizumab | EXPERIMENTAL | Abraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus demcizumab (3 cycles) and then Abraxane® and gemcitabine until disease progression |
| Arm 1 Pem, carbo, placebo x 4 cycles | PLACEBO_COMPARATOR | Pemetrexed (500 mg/m2),carboplatin (area under the concentration-time curve of 6 mg/mL x min) once every 21 days X 4 cycles, pemetrexed maintenance and placebo starting at Day 84 |
| Arm 2 Pem, carbo x 4 cycles, one course of dem | ACTIVE_COMPARATOR | Pemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, one course of demcizumab 5mg/kg, maintenance pemetrexed + placebo starting on Day 84 |
| Arm 3 pem, carbo, dem x 4 cycles, dem retreatment | ACTIVE_COMPARATOR | Pemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, maintenance pemetrexed starting on Day 84. 2 courses of demcizumab 5 mg/kg |
| Demcizumab and Pembrolizumab | EXPERIMENTAL | Demcizumab will be administered prior to pembrolizumab |
| Carboplatin and Pemetrexed plus demcizumab | EXPERIMENTAL | Carboplatin and Pemetrexed plus demcizumab |
| Pemetrexed plus demcizumab | EXPERIMENTAL | Pemetrexed plus demcizumab |
| Gemcitabine and demcizumab With or Without Abraxane® | EXPERIMENTAL | Gemcitabine and demcizumab With or Without Abraxane® |
| Open-label OMP-21M18 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Demcizumab | DRUG | administered intravenously |
| Abraxane® | DRUG | administered intravenously |
| gemcitabine | DRUG | administered intravenously |
| Placebo | DRUG | - |
| Pemetrexed | DRUG | - |
| Carboplatin | DRUG | - |
| Pembrolizumab | DRUG | Drug: Pembrolizumab administered 2mg/kg IV every 3 weeks |
| 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 pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed. 2. Availability of formalin-fixed paraffin-embedded (FFPE) ...
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OMP-21M18 is an investigational therapy being studied for the treatment of colorectal cancer and solid tumors. It has been evaluated in a Phase 1 trial in combination with FOLFIRI chemotherapy for patients with metastatic colorectal cancer, and in a separate Phase 1 dose escalation study in patients with solid tumors.
OMP-21M18 is being developed by Mereo BioPharma Group plc, which trades under the ticker MREO. The company has sponsored the clinical development of this agent, including a Phase 1 study of OMP-21M18 plus FOLFIRI in metastatic colorectal cancer and a Phase 1 dose escalation study in solid tumors.
OMP-21M18 is in Phase 1 clinical development. It has completed a Phase 1 dose escalation study in solid tumors and a Phase 1 study of OMP-21M18 plus FOLFIRI in metastatic colorectal cancer. No later-phase trials have been initiated, and the drug remains investigational.
OMP-21M18 has been evaluated in two completed Phase 1 trials. NCT00744562 was a dose escalation study in solid tumors conducted in the United States with 42 patients. NCT01189942 studied OMP-21M18 plus FOLFIRI as first or second line treatment in metastatic colorectal cancer in Australia and New Zealand with 18 patients.
OMP-21M18 is not approved and remains an investigational agent in Phase 1 clinical development. Both of its Phase 1 trials, one in solid tumors and one in metastatic colorectal cancer, have been completed. No regulatory approval has been granted for OMP-21M18 for any indication.