NCT05085977 (ADVANCED-1) is a Phase 1 clinical trial of TARA-002 in Non-muscle Invasive Bladder Cancer, sponsored by Protara Therapeutics.

Who is sponsoring NCT05085977?

NCT05085977 is sponsored by Protara Therapeutics.

What drugs are being tested in NCT05085977?

Interventions in NCT05085977: TARA-002.

What condition does NCT05085977 study?

NCT05085977 studies Non-muscle Invasive Bladder Cancer.

Is NCT05085977 still recruiting?

NCT05085977 is currently completed. Last updated 27 January 2025.

Last reviewed 2025-01-27 · How we verify

NCT05085977: ADVANCED-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1a)

Completed Phase 1 Last updated 27 January 2025

What this trial tests

Phase 1 trial testing TARA-002 in Non-muscle Invasive Bladder Cancer in 12 participants. Completed in 30 October 2024.

Timeline

10 March 2022

Primary endpoint
3 September 2024

30 October 2024

Quick facts

Lead sponsor	Protara Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	10 March 2022
Primary completion	3 September 2024
Estimated completion	30 October 2024
Sites	14 locations across Romania, Ukraine, United States, Moldova

Drugs / interventions tested

TARA-002 — full drug profile →

Conditions studied

Non-muscle Invasive Bladder Cancer — all drugs for Non-muscle Invasive Bladder Cancer →

Sponsor

Protara Therapeutics — full company profile →

Who can join

18 and older, any sex, with Non-muscle Invasive Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is an open-label dose escalation study (Phase 1a) 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. Dosing will start in subjects with HGTa or CIS (including CIS with concomitant Ta), and all subjects will receive 6 weeks of treatment at a fixed volume with varying dose levels.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Novel immunotherapeutic options for BCG-unresponsive high-risk non-muscle-invasive bladder cancer.
Hannouneh ZA, Hijazi A, Alsaleem AA, Hami S, et al · · 2023 · cited 26× · PMID 38037752 · DOI 10.1002/cam4.6768
Treatment Modalities for Non-Muscle Invasive Bladder Cancer: An Updated Review.
McNall S, Hooper K, Sullivan T, Rieger-Christ K, et al · · 2024 · cited 16× · PMID 38791924 · DOI 10.3390/cancers16101843
Emerging bladder-sparing treatments for high risk non-muscle invasive bladder cancer.
Gurbani CM, Chong YL, Choo ZW, Chia D, et al · · 2025 · cited 1× · PMID 40584211 · DOI 10.1177/23523735251348842

Verify or expand the search:

Other trials of TARA-002

Trials testing the same drug.

NCT05085990 — Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder · Phase 1 · completed

Other recruiting trials for Non-muscle Invasive Bladder Cancer

Currently open trials in the same condition.

NCT07206225 — A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer · Phase 1 · recruiting
NCT06503614 — A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
NCT06632964 — A Clinical Trial Aimed at Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder C · Phase 1 · recruiting
NCT07252297 — The Role of Universal Cancer Only Marker SIX6 in Diagnosing Non-Muscle Invasive Bladder Cancer · NA · active not recruiting
NCT04165317 — A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer · Phase 3 · active not recruiting

Other Protara Therapeutics trials

Trials by the same sponsor.

NCT05085990 — Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder · Phase 1 · completed
NCT05011370 — Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05085977 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Protara Therapeutics
Last refreshed: 27 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05085977.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing