TARA-002 for High-grade Bladder Cancer
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Recruiting
Phase 2
Interventional Study
Non-muscle Invasive Bladder Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 131 (estimated)
- Sponsor
- Protara Therapeutics · Industry
Who this trial is looking for
This trial is looking for adults with high-grade non-muscle invasive bladder cancer to test a treatment called TARA-002. Participants will undergo a specific type of treatment that is put directly into the bladder.
Are You a Good Fit for This Trial?
You may be able to join if
- I am 18 years of age or older.
- I have given written consent to join the study.
- I have high-grade non-muscle invasive bladder cancer.
- I have a specific type of bladder cancer called CIS or have had Ta/T1.
- I have not received intravesical BCG for at least 24 months, or I am naive to BCG.
- I am BCG unresponsive.
You may not be able to join if
- I have a penicillin allergy.
- I have been diagnosed with a variant type of bladder cancer.
- I have other issues affecting my prostate or upper urinary tract.
- I have ever had lymph node or metastatic cancer.
- I have a history of T2 bladder cancer or worse.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
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).
T…
Trial Locations
Loading…
Loading trial locations…
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 …
Contacts