臨床研究等提出・公開システム

Date of registration	July. 22, 2026
Last modified on	July. 22, 2026
Trial ID	jRCT2041260091

Scientific Title	A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naive High-Grade Non-Muscle Invasive Bladder Cancer (ADVANCED-3)
Public Title	Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naive High-grade Non-muscle Invasive Bladder Cancer (ADVANCED-3)

Contact for Scientific Queries	Name	Taira Hironori
	Affiliation	Syneos Health Japan K.K.
	Address	12F JP Tower, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-90-1790-0160
	E-mail	TARA-002-301@syneoshealth.com
Contact for Public Queries	Name	Taira Hironori
	Affiliation	Syneos Health Japan K.K.
	Address	12F JP Tower, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-90-1790-0160
	E-mail	TARA-002-301@syneoshealth.com

Recruitment status	Pending

Anticipated date of first enrollment		July. 22, 2026
Target sample size		28
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	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 histologic confirmation of high-grade non-muscle invasive CIS (with or without 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, or participants who received less than or equal to 2 doses of BCG within the 24 months prior to the most recent CIS diagnosis
	Exclusion Criteria	- Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory - Participants with central 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 or higher bladder cancer that existed at any point in time in the participant's history.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Non-Muscle Invasive Bladder Carcinoma
Intervention(s)		TARA-002 - Participants will receive 6 weekly instillations of TARA-002. Participants confirmed to have a complete response (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 (gemcitabine or mitomycin C) - 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.
Primary Outcome(s)		Incidence of high-grade complete response at Month 6 determined by cystoscopy, urine cytology, and bladder biopsy (if applicable)
Secondary Outcome(s)		- Duration of high-grade complete response - High-grade complete response rate at Months 3, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 - High-grade complete response rate at Month 6 in sub-group of participants with CIS only - Event-free survival (EFS) - Recurrence-free survival (RFS) - Progression-free survival (PFS) - Disease-specific progression-free survival (DSPFS) - Overall survival (OS) - Disease-specific survival (DSS) - Time to cystectomy - Time to recurrence-delayed cystectomy - Time to progression - Time to disease worsening - Incidence and severity of treatment emergent adverse events (TEAEs) - Incidence and severity of treatment emergent serious adverse events (TESAEs)

Primary Sponsor	Protara Therapeutics, Inc.

Name of Certified Review Board	Komaki City Hospital Institutional Review Board
Address	1-20, Jobushi, Komaki-shi, Aichi, 485-8520, Japan, Aichi
Telephone	+81-568-76-4131
E-Mail	druginfo@komakihp.gr.jp
Approval Status	Approval
Date of approval	June. 19, 2026

Plan to share IPD	No

Secondary ID(s)	NCT07480356

Countries of Recruitment（Except Japan）	Argentina/Australia/Brazil/Canada/China/South Korea/Taiwan/Ukraine/United States of America