Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TARA-002 · 5 trials · 5 indications
Incidence of high-grade complete response of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy determined by cystoscopy, urine cytology, and bladder biopsy (if applicable)
AE = adverse event
DLT = dose limiting toxicities; HGTa = high grade Ta; CIS = carcinoma in situ, includes CIS with concomitant Ta
MTD = maximum tolerated dose; RP2D = recommended Phase 2 dose
| Arm | Type | Description |
|---|---|---|
| TARA-002 (Arm A) | EXPERIMENTAL | - |
| Investigator's choice of intravesical chemotherapy | ACTIVE_COMPARATOR | - |
| TARA-002 | EXPERIMENTAL | TARA-002 is a lyophilized biological preparation for injection containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin. |
| Name | Type | Description |
|---|---|---|
| TARA-002 | DRUG | Participants will receive 6 weekly instillations of TARA-002. Participants confirmed to have a CR at Week 12 will enter the maintenance treatment period and will receive 3 additional weekly instillations of TARA-002 every 3 months up to Month 19, and then 3 weekly doses at Month 25. Participants who are eligible for reinduction at Week 12 will receive 6 additional weekly instillations of TARA-002. Participants who undergo reinduction and are confirmed to have a CR at Week 24 will enter the maintenance regimen treatment period and will receive 3 weekly instillations of TARA-002 every 3 months up to Month 19, and then 3 weekly doses at Month 25. |
| Investigator's Choice of Intravesical Chemotherapy | DRUG | Participants will receive 6 weekly instillations of Investigator's choice of intravesical chemotherapy. Participants confirmed to have a CR at Week 12 will enter the maintenance regimen treatment period and will receive one intravesical instillation of Investigator's choice of intravesical chemotherapy every 1 month up to Month 25. |
Inclusion Criteria: * Male or female participants 18 years of age or older at the time of signing informed consent * Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry * Central ...
TARA-002 is an investigational therapy being studied for non-muscle invasive bladder cancer, including high-grade disease and carcinoma in situ, and for lymphatic malformations in pediatric patients. It is administered by intravesical instillation for bladder cancer and intracystic injection for lymphatic malformations.
TARA-002 is being developed by Protara Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker TARA. The company is conducting clinical trials of TARA-002 in both oncology and lymphatic malformation indications.
TARA-002 is in Phase 3 clinical development for BCG-naive high-grade non-muscle invasive bladder cancer. It has completed Phase 1 trials in non-muscle invasive bladder cancer and is in a Phase 2 trial for lymphatic malformations. It is an investigational drug and not yet approved.
TARA-002 is being studied in several trials. NCT07480356 is a Phase 3 trial comparing intravesical TARA-002 to investigator's choice chemotherapy in BCG-naive high-grade non-muscle invasive bladder cancer. NCT05871970 is a Phase 2 trial of intracystic TARA-002 for lymphatic malformations in patients aged 6 months to under 18 years. Two Phase 1 trials, NCT05085977 and NCT05085990, have been completed.
TARA-002 has received Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration. These designations are intended to expedite the development and review of the drug for its studied indications.
TARA-002 is a distinct investigational therapy being developed by Protara Therapeutics. It is being studied as a potential treatment for non-muscle invasive bladder cancer, particularly in patients who have not received BCG therapy, and is compared against standard intravesical chemotherapy in its Phase 3 trial.