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Clinical Trials List

Protocol NumberTARA-002-101-Ph2

NCT Number(ClinicalTrials.gov Identfier)NCT05951179

Not yet recruiting

2026-06-16 - 2031-09-30

Phase II

Not yet recruiting4

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

Trial Applicant

Syneos Health
Sponsor

Taiwan Syneos Health Company Limited
Trial scale

Multi-Regional Multi-Center
Update

2026/09/14

Investigators and Locations

Principal Investigator 羅浩倫無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 黃冠華無

Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Shu-Pin Huang 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator See-Tong Pang

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Non-muscle Invasive Bladder Cancer

Objectives

TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF. Participants will be enrolled into one of 2 cohorts: Cohort A: Participants with CIS (± Ta/T1) who are BCG naive, or Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis Cohort B: Participants who are BCG unresponsive

Test Drug

TARA-002

Active Ingredient

Streptococcus pyogenes (A Group, Type 3)

Dosage Form

Lyophilized powder for injection

Dosage

40 KE

Endpoints

Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002 Month 3 to Month 60

Inclution 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 (± 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 (± Ta/T1) who are BCG unresponsive.

Exclusion Criteria

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

The Estimated Number of Participants

Taiwan

5 participants
Global

131 participants