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TARA-002 for Non-muscle Invasive Bladder Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-muscle Invasive Bladder CancerTARA-002 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new intravesical treatment for high-grade non-muscle invasive bladder cancer (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy. The trial will test different dose levels to see what is safe and effective. All subjects will receive 6 weeks of treatment.

Eligible Conditions
  • Non-muscle Invasive Bladder Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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AU-011
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PLZ4-coated paclitaxel-loaded micelles (PPM)

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Day 1 to Day 43

Day 43
Phase 1a, Dose Escalation Phase: Incidence of DLT AEs in subjects with HGTa or CIS NMIBC
Phase 1a, Dose Escalation Phase: MTD and RP2D of TARA-002 in subjects with HGTa or CIS NMIBC

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
UGN-301
1
AU-011
1
PLZ4-coated paclitaxel-loaded micelles (PPM)

Trial Design

1 Treatment Group

TARA-002
1 of 1

Experimental Treatment

18 Total Participants · 1 Treatment Group

Primary Treatment: TARA-002 · No Placebo Group · Phase 1

TARA-002
Biological
Experimental Group · 1 Intervention: TARA-002 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to day 43

Who is running the clinical trial?

Protara TherapeuticsLead Sponsor
2 Previous Clinical Trials
312 Total Patients Enrolled
Chief Scientific Operations OfficerStudy DirectorProtara Therapeutics
2 Previous Clinical Trials
312 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female, and you are 18 years of age or older at the time of signing the informed consent.
You have given informed consent after the nature of the study has been explained according to applicable requirements prior to study entry.
Subjects who are treatment naïve, are unable to obtain intravesical BCG for the treatment of NMIBC, have received at least one dose of intravesical BCG, or at least one dose of intravesical chemotherapy.
References

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