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Also known as BC-819, inodiftagene vixteplasmid
DTA-H19 · 5 trials · 5 indications
Tumor response evaluated at week 9 (range 8-10 weeks) during the first post induction course treatment cystoscopy or TUR of suspiciaous lesions
If 2 patients in any cohort experience DLTs, then the next lower dose will be considered the MTD if there is a lower dose cohort. A DLT is defined as grade 3 or greater toxicity judged to be at least possibly related to the investigational products.
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 |
|---|---|---|
| 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 |
| BC-819 | EXPERIMENTAL | Intratumoral administration of BC-819 |
| 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 |
| DTA-H19 | BIOLOGICAL | Cohort #1: 4 mg DTA-H19 intratumorally 2 times per week for 2 weeks Cohort #2: 8 mg DTA-H19 intratumorally 2 times per week for 2 weeks |
| 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: 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...
DTA-H19 is an investigational oncology therapy being studied in bladder neoplasms and pancreatic neoplasms. It has been tested in a Phase 1 study in patients with superficial bladder cancer and a Phase 1/2a study in patients with unresectable pancreatic cancer. It is not an approved treatment.
DTA-H19 is being developed by Chemomab Therapeutics Ltd., which trades under the ticker CMMB. The company is the sponsor associated with the clinical development of this oncology asset.
DTA-H19 is in Phase 1 development. It has completed one Phase 1 trial in superficial bladder cancer and one Phase 1/2a trial in unresectable pancreatic cancer. No active trials are currently listed, and the drug remains investigational rather than approved.
DTA-H19 has been evaluated in two completed studies: NCT00393809, a Phase 1 safety and proof of concept study of intravesical DTA-H19 in patients with superficial bladder cancer in Israel, and NCT00711997, a Phase 1/2a study in patients with unresectable pancreatic cancer conducted in the United States and Israel.
The DTA-H19 clinical program enrolled a total of 18 patients in its bladder cancer study and 9 patients in its pancreatic cancer study. Both were open-label, uncontrolled trials without randomization or blinding, and both have been completed.