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Also known as bispecific monoclonal antibody
OMP-305B83 · 2 trials · 4 indications
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in subjects treated with OMP-305B83 in combination with Paclitaxel
Number of subjects with a DLT
Number of subjects with adverse events
| Arm | Type | Description |
|---|---|---|
| OMP-305B83 plus paclitaxel | EXPERIMENTAL | - |
| OMP-305B83 | EXPERIMENTAL | The dose levels of OMP-305B83 will be 0.5, 1.0, 2.5, 5 and 10 mg/kg administered IV once every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| OMP-305B83 | DRUG | intravenous (in the vein) infusion |
| Paclitaxel | DRUG | administered intravenously |
Inclusion Criteria: 1. Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer 2. Measureable disease per response evaluation criteria (RECIST) v1.1 3. Prior bevacizumab 4. Age \> or = 21 years 5. Adequate organ and marrow function 6. For women of childbearing potential...
OMP-305B83 is an investigational small molecule developed by Mereo BioPharma Group plc for advanced solid tumor malignancies and ovarian cancer. It has been studied in Phase 1 clinical trials and is not approved for any indication. The program targets DLL4, a protein involved in tumor blood vessel formation.
OMP-305B83 was studied as a treatment for advanced solid tumor malignancies and for ovarian, peritoneal, or fallopian tube cancer. It was evaluated in Phase 1 trials, including one combining it with paclitaxel in ovarian, peritoneal, or fallopian tube cancer. It remains investigational and is not approved for these uses.
OMP-305B83 targets DLL4, a protein in the Notch signaling pathway that regulates tumor angiogenesis. By binding DLL4, the drug is designed to disrupt blood vessel formation that supports tumor growth. This mechanism was the basis for its evaluation in advanced solid tumors and ovarian cancer.
Mereo BioPharma Group plc, which trades on Nasdaq under the ticker MREO, is the developer of OMP-305B83. The company advanced the asset into Phase 1 clinical testing in oncology, studying it in advanced solid tumor malignancies and in ovarian, peritoneal, or fallopian tube cancer.
OMP-305B83 is in Phase 1 development and is investigational. It has not been approved by the FDA for any indication. Two Phase 1 studies have been completed, one in advanced solid tumors and one in ovarian, peritoneal, or fallopian tube cancer in combination with paclitaxel.
OMP-305B83 has been studied in two completed Phase 1 trials. NCT02298387 evaluated the drug in advanced solid tumors and enrolled 71 participants. NCT03030287 tested OMP-305B83 plus paclitaxel in ovarian, peritoneal, or fallopian tube cancer and enrolled 44 participants. Both trials were conducted in the United States.