Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BC-819/PEI · 2 trials · 2 indications
Tumor response evaluated at week 9 (range 8-10 weeks) during the first post induction course treatment cystoscopy or TUR of suspiciaous lesions
| Arm | Type | Description |
|---|---|---|
| 20 mg of BC-819/PEI | EXPERIMENTAL | Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer \[recurrent stages Ta (low or high grade) and T1 (low grade) TCC\] who have failed prior intravesical therapies including BCG and/or chemotherapy. |
| BC-819/PEI and BCG alternating | EXPERIMENTAL | 4 or 6 weekly treatments of BC-819/PEI alternating with 6 treatments of BCG |
| BC-819/PEI and BCG Vaccine sequential | EXPERIMENTAL | 4 weekly treatments of BC-819/PEI followed by 6 weekly treatments of BCG |
| twice-weekly treatments of BC-819 and BCG | EXPERIMENTAL | 6 twice-weekly treatments of BC-819/PEI and BCG |
| Name | Type | Description |
|---|---|---|
| BC-819/PEI | BIOLOGICAL | Papillary tumors will be resected with the exception of one marker tumor that will remain to examine the effects of the treatment on the remaining tumor. Study treatments will consist of an induction course of six weekly instillations of 20 mg of DTA-H19/PEI into the urinary bladder. Intravesical therapy will be delivered through a Foley catheter. Patients will be instructed to hold the dose in the bladder for two hours after administration. If the patient has a complete response, then she/he will be eligible to receive three additional courses of 3 weekly intravesical administrations of the same dose of investigational product every 12 weeks. |
| BCG Vaccine | DRUG | intravesical instillations |
Inclusion Criteria: To be eligible to participate in this study, patients must: 1. Provide written informed consent. 2. Have intermediate-risk recurrent superficial TCC of the bladder defined as Stage Ta (low or high grade) or T1 (but with penetration into no more than ½ of the lamina propria), lo...
BC-819 is an investigational oncology therapy being studied for transitional cell carcinoma of the bladder, ovarian cancer, and superficial bladder cancer. It is a monoclonal antibody developed by Chemomab Therapeutics Ltd. (CMMB). The drug is currently in Phase 1 clinical development.
BC-819 is a monoclonal antibody, but its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its potential effects in treating bladder and ovarian cancers, though the precise mechanism of action remains unspecified in public data.
BC-819 is being developed by Chemomab Therapeutics Ltd., a biopharmaceutical company traded on the Nasdaq under the ticker CMMB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating certain cancers, including bladder and ovarian cancer.
BC-819 is currently in Phase 1 clinical development. It has completed one Phase 1 trial and one Phase 1/2a trial, as well as a Phase 2b trial, all of which are finished. The drug remains investigational and has not been approved by regulatory authorities.
BC-819 has been studied in three completed clinical trials: NCT00595088, a Phase 2b trial in superficial bladder cancer with 47 participants; NCT00826150, a Phase 1/2a trial in ovarian cancer with 14 participants; and NCT01878188, a Phase 1 pilot study in transitional cell bladder carcinoma with 38 participants.
Yes, BC-819 is also known as DTA-H19. Clinical trial records refer to the drug as DTA-H19 in studies for superficial bladder cancer and ovarian cancer, while the name BC-819 is used in a pilot study for transitional cell bladder carcinoma. Both names refer to the same investigational therapy.