TARA-002 for Bladder Cancer
(ADVANCED-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Chief Scientific Operations Officer
Principal Investigator
Protara Therapeutics
Are You a Good Fit for This Trial?
Adults over 18 with high-grade non-muscle invasive bladder cancer who are treatment-naive, can't get BCG therapy, or have had at least one dose of BCG or chemotherapy. Not for those with metastatic disease, penicillin allergy without clearance from an allergy test, recent advanced bladder cancer stages, or certain histological variants.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravesical instillation of TARA-002 for 6 weeks to evaluate safety and toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TARA-002
Find a Clinic Near You
Who Is Running the Clinical Trial?
Protara Therapeutics
Lead Sponsor