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A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer (ADVANCED-2)

Safety and efficacy study of intravesical instillation of TARA-002 in adults with high-grade non-muscle invasive bladder cancer (ADVANCED-2)

Hideaki Ueda

Syneos Health Japan K.K.

12F JP Tower, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo

TARA-002-101-Ph2@syneoshealth.com

Hideaki Ueda

Syneos Health Japan K.K.

12F JP Tower, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo

+81-70-6427-3501

TARA-002-101-Ph2@syneoshealth.com

Recruiting

June. 30, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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 histologic confirmation of high-grade non-muscle invasive CIS (plus or minus Ta/T1) with active disease
- Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with CIS (plus or minus Ta/T1) who are BCG unresponsive.

- Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory.
- Participants with centrally confirmed variant histology, including adenocarcinoma or squamous cell carcinoma.
- Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment.
- Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past).
- Any history of >= T2 bladder cancer that existed at any point in time in the participant's history.

Both

Non-muscle Invasive Bladder Cancer

All participants will receive 6 weekly instillations of TARA-002 at the established RP2D (First Treatment Period). Participants who are eligible for reinduction after the First Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part of the Second Treatment Period. Participants confirmed to have a complete response after the First Treatment Period will receive 3 additional weekly doses of TARA-002 instillation as maintenance during the Second Treatment Period. All eligible participants will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment Period (maintenance) at Months 6, 9, 12, 15, 18, and 24. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 27 until Month 60.

- Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002

- Duration of high-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
- High-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
- Incidence of high-grade Complete Response at any time by subgroup (BCG naive and BCG exposed > 24 months) according to central pathology
- Duration of Complete Response (all recurrent bladder cancer, including low grade Ta) after treatment with TARA-002
- Complete Response rate (all recurrent bladder cancer, including low grade Ta) at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
- Progression free survival after treatment with TARA-002
- Disease-specific progression free survival after treatment with TARA-002
- Overall survival after treatment with TARA-002
- Disease specific survival after treatment with TARA-002
- Time to cystectomy after treatment with TARA-002
- Time to recurrence delayed cystectomy after treatment with TARA-002
- Time to progression after treatment with TARA-002
- Time to disease worsening after treatment with TARA-002
- Incidence and severity of AEs, TEAEs, SAEs and TESAEs after treatment with TARA-002

+81-45-722-8655

April. 11, 2025

No

US/Ukraine/China/Canada/Brazil/Argentina/South Korea/Taiwan