Testing TARA-002 for non-muscle invasive bladder cancer
Official title: Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
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
- Phase 2
- 1 group
- Sites in Abbotsford British Columbia, Brampton and 2 more cities
- Recruiting
Interventions
- Biological therapy
TARA-002
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.
Canadian Sites (5)
2 of 5 recruiting
- Recruiting
UHN Princess Margaret Cancer Centre Princess Margaret Hospital
Toronto, Ontario
- Recruiting
The Research Institute of the McGill University Health Centre
Montreal, Quebec
- Stopped early
Exdeo Clinical Research Inc
Abbotsford British Columbia, British Columbia
- Withdrawn
Jonathan Giddes Medicine Professional Corporation
Brampton, Ontario
- Withdrawn
Sunnybrook Research Institute
Toronto, Ontario
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female participants 18 years of age or older at the time of signing informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +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 (CohortCohortA group of participants sharing a characteristic, followed together.Read more → A). Participants with CIS (± Ta/T1) who are BCG unresponsive.
Exclusion
- −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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 criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more →, please contact the SponsorSponsorThe organisation responsible for the study overall.Read more →
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives TARA-002.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 131 people.
The study is currently expected to finish around March 2032.
The main measurement is taken over: Month 3 to Month 60.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
CohortCohortA group of participants sharing a characteristic, followed together.Read more → A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002 — measured over Month 3 to Month 60.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05951179 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About TARA-002Biological
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.
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Month 3 to Month 60.
The study as a whole is currently expected to finish around 2032-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 131 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 12 locations, including: Abbotsford British Columbia, British Columbia, Canada; Brampton, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Bloomington, Minnesota, United States; Rochester, Minnesota, United States, and 6 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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
Other Sites (8)
Minnesota Urology, Woodbury
Bloomington, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
AccuMed Research Associates
Garden City, New York, United States
Laura & Isaac Perlmutter Cancer Center - NYU Langone Health
New York, New York, United States
University of Rochester, Department of Urology
Rochester, New York, United States
Associated Medical Professionals of NY, PLLC
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Spokane Urology
Spokane, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.