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Tests treatment safety and results 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
ClinicalTrials.gov ID: NCT05951179
What this study is testing
What is TARA-002?
TARA-002 is an investigational medicine, given as an once-weekly, being studied as a potential treatment for non-muscle invasive bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Homewood, Alabama, United States
- Phoenix, Arizona, United States
- Queen Creek, Arizona, United States
- Little Rock, Arkansas, United States
- Bakersfield, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Diego, California, United States
- Torrance, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Lakewood, Colorado, United States
- Lone Tree, Colorado, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Lake Barrington, Illinois, United States
- Lafayette, Louisiana, United States
- Shreveport, Louisiana, United States
- Boston, Massachusetts, United States
- Bloomington, Minnesota, United States
+ 41 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homewood, Alabama, United States; Phoenix, Arizona, United States; Queen Creek, Arizona, United States; Little Rock, Arkansas, United States; Bakersfield, California, United States; Los Angeles, California, United States and 55 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.