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NCT05085990 · ClinicalTrials.gov registry record · Phase 1
Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1b)
A Phase 1 study, sponsored by Protara Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT05085990 is a Phase 1 study that has completed, run by Protara Therapeutics. The registered enrollment target is 10 participants.
The verdict
NCT05085990, a Phase 1 study, has completed, sponsored by Protara Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study is open-label dose expansion study to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to obtain intravesical Bacillus Calmette-Guérin (BCG), adults who have received at least one dose of intravesical BCG or adults who have received at least one dose of intravesical chemotherapy. After completion of the dose escalation phase (Phase 1a) and after the RP2D has been established, the dose expansion phase (Phase 1b) will start enrollment of subjects with CIS NMIBC with active disease to further evaluate the safety and preliminary efficacy of TARA-002, at the established RP2D. CIS NMIBC with active disease is defined as disease present at the last cystoscopic evaluation prior to signing the ICF. Subjects enrolled in the dose expansion phase will not include subjects previously enrolled and treated in the dose escalation phase. All subjects will receive 6 weeks of treatment at the established RP2D.
Interventions
- BIOLOGICAL TARA-002
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-05-08 |
| Est. Completion | 2024-09-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05085990
The ClinicalTrials.gov registry entry for NCT05085990 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Protara Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TARA-002 is the first listed.
NCT05085990 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05085990 about?
NCT05085990 is a clinical study titled "Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1b)". This study is open-label dose expansion study to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to obtain intravesi...
What is the current status of trial NCT05085990?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-05-08. Estimated completion is 2024-09-12.
What interventions are being tested in trial NCT05085990?
The interventions under investigation include: TARA-002 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05085990?
This trial is sponsored by Protara Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
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