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 carcinoma in situ, and for lymphatic malformations in pediatric patients. It is administered intravesically or intracystically, depending on the condition being treated.
TARA-002 targets NOD2 and TLR2, which are pattern recognition receptors involved in innate immune signaling. By engaging these targets, the therapy is designed to stimulate an immune response against the disease.
TARA-002 is being developed by Protara Therapeutics, Inc., a company traded on the stock exchange under the ticker TARA. The company is conducting clinical trials to evaluate the therapy's safety and efficacy.
TARA-002 is in Phase 3 clinical development for non-muscle invasive bladder cancer. It is also being studied in Phase 2 trials for lymphatic malformations and in additional Phase 2 trials for bladder cancer. The therapy is investigational and not yet approved.
TARA-002 is being evaluated in several trials, including NCT07480356, a Phase 3 study comparing it to intravesical chemotherapy in BCG-naive high-grade non-muscle invasive bladder cancer. Other trials include NCT05951179 and NCT05871970, both Phase 2 studies, and the completed Phase 1 trial NCT05085990.
TARA-002 is the primary name for this investigational therapy. No alternative names have been reported for the drug in clinical trial registrations or company communications.