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 small molecule therapeutic being developed by Protara Therapeutics, Inc. for bladder cancer and lymphatic malformation. It is administered intravesically for non-muscle invasive bladder cancer and intracystically for lymphatic malformation. The program includes a Phase 3 trial in BCG-naïve high-grade non-muscle invasive bladder cancer and Phase 2 studies in bladder cancer and lymphatic malformation.
TARA-002 is being studied for non-muscle invasive bladder cancer, including BCG-naïve high-grade disease and cases with carcinoma in situ. It is given by intravesical instillation. The Phase 3 trial NCT07480356 compares intravesical TARA-002 with investigator's choice of intravesical chemotherapy in BCG-naïve high-grade non-muscle invasive bladder cancer.
TARA-002 targets NOD2 and TLR2. These are pattern recognition receptors involved in innate immune signaling. By engaging NOD2 and TLR2, TARA-002 is designed to stimulate an immune response. It is classified as a small molecule and is delivered locally, intravesically for bladder cancer and intracystically for lymphatic malformation.
TARA-002 is being developed by Protara Therapeutics, Inc., which trades under the ticker TARA. The company is running the clinical program across bladder cancer and lymphatic malformation indications, including a Phase 3 trial in BCG-naïve high-grade non-muscle invasive bladder cancer and Phase 2 trials in bladder cancer and lymphatic malformation.
TARA-002 is in Phase 3 development. The Phase 3 trial NCT07480356 is recruiting participants with BCG-naïve high-grade non-muscle invasive bladder cancer. Earlier studies include the completed Phase 1b trial NCT05085990 and two Phase 2 trials, NCT05951179 in non-muscle invasive bladder cancer and NCT05871970 in lymphatic malformation. TARA-002 is investigational and has not been approved.
TARA-002 has been studied in four registered trials. The Phase 3 trial NCT07480356 is recruiting in the United States and Ukraine. Phase 2 trials include NCT05951179 in non-muscle invasive bladder cancer across multiple countries and NCT05871970 in lymphatic malformation in the United States. The Phase 1b trial NCT05085990 is completed.