Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer

NCT07480356 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: TARA-002-301
• Study Type: interventional
• Target: 284
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older. The main questions it aims to answer are:

• Can the study drug help participants with this type of cancer?
• Is the study drug safe?
• What are the side effects of the study drug? Researchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.

Conditions

Bladder (Urothelial, Transitional Cell) Cancer; Non-Muscle Invasive Bladder Carcinoma; Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

Keywords

BCG-naive; Non-muscle invasive bladder Cancer; bladder cancer; carcinoma in situ

Outcome Measures

Primary Outcomes (1)

• Incidence of high-grade complete response

  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)

  Month 6

Secondary Outcomes (15)

• Duration of high-grade complete response

  Up to Month 60

• Treatment emergent adverse events

  Up to Month 60

• Treatment emergent serious adverse events

  Up to Month 60

• 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 (CIS only)

  Month 6

Study Arms (2)

TARA-002 (Arm A)

EXPERIMENTAL

Drug: TARA-002

Investigator's choice of intravesical chemotherapy

ACTIVE COMPARATOR

Drug: Investigator's Choice of Intravesical Chemotherapy

Interventions

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.

TARA-002 (Arm A)

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.

Investigator's choice of intravesical chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (± 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 ≤2 doses of BCG within the 24 months prior to the most recent CIS diagnosis

You may not qualify if:

• Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory Central confirmed variant histology
• 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
• For more information on eligibility criteria, please contact the Sponsor.

Sponsors & Collaborators

• Protara Therapeutics: lead

MeSH Terms

Conditions

Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms; Carcinoma in Situ

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Chief R&D Officer

CONTACT

16468440337; clinicaltrials@protaratx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants receiving Investigator's choice of intravesical chemotherapy who are treatment failures and have CIS (±Ta) at any response assessment are eligible for crossover to TARA-002, provided they still meet all other study-specified eligibility requirements.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): November 1, 2032
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share