NCT05951179 Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
| NCT ID | NCT05951179 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Protara Therapeutics |
| Condition | Non-muscle Invasive Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 131 participants |
| Start Date | 2023-09-15 |
| Primary Completion | 2031-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 131 participants in total. It began in 2023-09-15 with a primary completion date of 2031-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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 (± 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
Contact & Investigator
Chief Scientific Operations Officer
STUDY DIRECTOR
Protara Therapeutics
Frequently Asked Questions
Who can join the NCT05951179 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-muscle Invasive Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05951179 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05951179 currently recruiting?
Yes, NCT05951179 is actively recruiting participants. Contact the research team at clinicaltrials@protaratx.com for enrollment information.
Where is the NCT05951179 trial being conducted?
This trial is being conducted at Homewood, United States, Phoenix, United States, Queen Creek, United States, Little Rock, United States and 11 additional locations.
Who is sponsoring the NCT05951179 clinical trial?
NCT05951179 is sponsored by Protara Therapeutics. The principal investigator is Chief Scientific Operations Officer at Protara Therapeutics. The trial plans to enroll 131 participants.
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