Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 patients with 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 dose escalation study conducted in the United States.
Mereo BioPharma Group plc, which trades under the ticker MREO, is the developer associated with OMP-54F28, Nab-Paclitaxel and Gemcitabine. The company's pipeline covers the OMP-54F28 program, including this pancreatic cancer combination regimen and the other OMP-54F28 combination studies in ovarian cancer, hepatocellular cancer, and solid tumors.
OMP-54F28, Nab-Paclitaxel and Gemcitabine is in Phase 1 development. The pancreatic cancer combination was studied in a single Phase 1 dose escalation trial that has completed. No Phase 2 or later studies of this specific regimen are listed, so it remains an investigational combination rather than an approved treatment.
The regimen was studied in NCT02050178, a Phase 1 dose escalation trial titled Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer. The trial enrolled 26 patients, was conducted in the United States, and has completed.
OMP-54F28, Nab-Paclitaxel and Gemcitabine has been studied in previously untreated Stage IV pancreatic cancer. The broader OMP-54F28 program also includes combination studies in ovarian cancer, hepatocellular cancer, and solid tumors, but the nab-paclitaxel and gemcitabine regimen itself was evaluated specifically in the pancreatic cancer setting.