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

NCT05085977 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-01-27

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Protara Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chief Scientific Operations Officer · Protara Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2024-09-03
Completion
2024-10-30
FDA Drug
Yes

Countries

  • United States
  • Moldova
  • Romania
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05085977 on ClinicalTrials.gov