Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:32 AM
Study NCT ID:
NCT07480356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Protara Therapeutics
Organization:
Study Overview
Official Title:
A Phase 3, Randomized Study to Evaluate the 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADVANCED-3
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: