Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BC-819 · 1 trial · 1 indication
A dose limiting toxicity (DLT) was defined as any grade 3 or greater non-hematologic AE by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). If one subject in a cohort experienced a DLT, then three additional subjects had to be enrolled to that cohort unless a second subject in that cohort experiences a DLT. The next lower dose was to be considered the MTD.
| Arm | Type | Description |
|---|---|---|
| BC-819 | EXPERIMENTAL | BC-819 60, 120 and 240 mg IP administration |
| Name | Type | Description |
|---|---|---|
| BC-819 | BIOLOGICAL | Cohort #1: 60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course. Cohort #2: 120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course. Cohort #3: 240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course. |
Inclusion Criteria: * Provide written informed consent and be at least 18 years of age. * Have histopathologically documented epithelial ovarian carcinoma or primary peritoneal carcinoma with evidence of ascites. * Have either a) platinum-refractory disease (i.e. persistent disease following comple...
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BC-819 is an investigational monoclonal antibody being developed for oncology indications, specifically ovarian cancer, superficial bladder cancer, and transitional cell carcinoma of the bladder. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BC-819 is being developed by Chemomab Therapeutics Ltd., a biopharmaceutical company. The company's stock is traded under the ticker symbol CMMB. The drug is in Phase 1 clinical development for oncology indications.
BC-819 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. Clinical trials for the drug have been completed, including studies in ovarian cancer and bladder cancer indications.
BC-819 has been studied in three completed clinical trials. These include NCT00595088, a Phase 2b trial in superficial bladder cancer with 47 participants; NCT00826150, a Phase 1/2a study in ovarian cancer with 14 participants; and NCT01878188, a Phase 1 pilot study in transitional cell carcinoma of the bladder with 38 participants.
Yes, BC-819 is also known as DTA-H19. Clinical trial records refer to the drug as DTA-H19, including studies in superficial bladder cancer and ovarian cancer. The drug is being developed by Chemomab Therapeutics Ltd. under the ticker CMMB.