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

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

March 10, 2022

Primary Completion Date

September 3, 2024

Study Completion Date

October 30, 2024

Conditions
Non-muscle Invasive Bladder Cancer
Interventions
BIOLOGICAL

TARA-002

Phase 1a, Dose Escalation: First, up to 3 dose levels of TARA-002 (10 KE → 20 KE → 40 KE) will be tested sequentially with 6 weekly intravesical doses starting with the lowest dose using a 3+3 design in a dose escalation manner until the RP2D has been established. If the MTD is not reached, additional cohorts of dose levels higher than 40 KE may be explored.

Trial Locations (14)

10731

Spitalul Clinic de Nefrologie Carol Davila, Bucharest

12603

Premier Medical Group of the Hudson Valley, Poughkeepsie

14642

University of Rochester, Department of Urology, Rochester

21204

Chesapeake Urology Research Associates, Baltimore

29572

Carolina Urologic Research Center, Myrtle Beach

32224

Mayo Clinic, Jacksonville

37209

Urology Associates PC, Nashville

55905

Mayo Clinic, Rochester

70112

Tulane Medical Center, New Orleans

78229

UT Health San Antonio, San Antonio

90089

USC Norris Cancer Center, Los Angeles

08054

New Jersey Urology, Mount Laurel

Unknown

"PMSI Republican Clinical Hospital T. Mosneaga, ARENSIA Exploratory Medicine Phase I Unit", Chisinau

08111

Arensia Kapitanivka, Kapitanivka

Sponsors
All Listed Sponsors
lead

Protara Therapeutics

INDUSTRY