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Also known as OMP-54F28
OMP-54F28, Nab-Paclitaxel and Gemcitabine · 4 trials · 6 indications
The maximum tolerated dose (MTD) will be determined in patients treated with OMP-54F28 in combination with sorafenib in patients with hepatocellular cancer
The maximum tolerated dose (MTD) will be determined in patients treated with OMP-54F28/paclitaxel/carboplatin (from Day 0 - 21)
The maximum tolerated dose (MTD) will be determined in patients treated with gemcitabine in combination with weekly nab-paclitaxel (from Day 0 - 28)
| Arm | Type | Description |
|---|---|---|
| Drug: OMP-54F28, with Sorafenib | EXPERIMENTAL | - |
| Drug: OMP-54F28, Paclitaxel and Carboplatin | EXPERIMENTAL | - |
| Drug: OMP-54F28, Nab-Paclitaxel and Gemcitabine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| OMP-54F28 with Sorafenib | DRUG | - |
| OMP-54F28, Paclitaxel and Carboplatin | DRUG | - |
| OMP-54F28, Nab-Paclitaxel and Gemcitabine | DRUG | - |
| OMP-54F28 | BIOLOGICAL | dose escalation of 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks |
Inclusion Criteria: * Signed Informed Consent Form * Age ≥18 years * Histologically documented hepatocellular carcinoma * Locally advanced or metastatic disease * Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy o Tumor tissue from fine needle as...
OMP-54F28, Nab-Paclitaxel and Gemcitabine is a Phase 1 combination regimen studied in previously untreated Stage IV pancreatic cancer. It pairs the investigational agent OMP-54F28 with two chemotherapy drugs, nab-paclitaxel and gemcitabine. The combination was evaluated in a completed dose escalation trial, NCT02050178, which enrolled 26 patients in the United States.
OMP-54F28, Nab-Paclitaxel and Gemcitabine was studied for previously untreated Stage IV pancreatic cancer. OMP-54F28 has also been tested in other combinations across hepatocellular cancer, ovarian cancer, and solid tumors. All of these programs were Phase 1 dose escalation studies, and the pancreatic cancer trial enrolled 26 patients.
Mereo BioPharma Group plc, which trades under the ticker MREO, is the developer associated with OMP-54F28 and its combination regimens. The company's pipeline includes OMP-54F28 studied alongside nab-paclitaxel and gemcitabine, as well as with paclitaxel and carboplatin, and with sorafenib in separate Phase 1 trials.
OMP-54F28, Nab-Paclitaxel and Gemcitabine is in Phase 1 development. The combination was evaluated in a single Phase 1 dose escalation study, NCT02050178, in patients with previously untreated Stage IV pancreatic cancer. That trial is completed, and the regimen is investigational rather than an approved treatment.
The combination was tested in NCT02050178, a completed Phase 1 dose escalation study of OMP-54F28 with nab-paclitaxel and gemcitabine in previously untreated Stage IV pancreatic cancer. It enrolled 26 patients in the United States. OMP-54F28 was also studied in NCT02092363, NCT02069145, and NCT01608867 with other agents or as monotherapy.