Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for the treatment of advanced solid tumor malignancies, including ovarian cancer. It is in Phase 1 clinical development and is not yet approved by the FDA.
OMP-305B83 is being developed by Mereo BioPharma Group plc, a biopharmaceutical company traded on the NASDAQ under the ticker MREO.
OMP-305B83 is in Phase 1 clinical development. Two Phase 1 studies have been completed, one as a single agent and one in combination with paclitaxel. The drug remains investigational and has not been approved.
OMP-305B83 has been studied in two completed Phase 1 trials. NCT02298387 evaluated the drug as a single agent in 71 subjects with advanced solid tumors. NCT03030287 evaluated OMP-305B83 plus paclitaxel in 44 female subjects with ovarian, peritoneal, or fallopian tube cancer.
OMP-305B83 is also known as navicixizumab. It is a bispecific antibody that targets both DLL4 and VEGF, and it is being developed for use in oncology.