Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05085990
Other study ID # TARA-002-101(Phase 1b)
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 8, 2023
Est. completion date August 2024

Study information

Verified date May 2024
Source Protara Therapeutics
Contact Chief Scientific Operations Officer
Phone 16468440337
Email clinicaltrials@protaratx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is open-label dose expansion study 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. After completion of the dose escalation phase (Phase 1a) and after the RP2D has been established, the dose expansion phase (Phase 1b) will start enrollment of subjects with CIS NMIBC with active disease to further evaluate the safety and preliminary efficacy of TARA-002, at the established RP2D. CIS NMIBC with active disease is defined as disease present at the last cystoscopic evaluation prior to signing the ICF. Subjects enrolled in the dose expansion phase will not include subjects previously enrolled and treated in the dose escalation phase. All subjects will receive 6 weeks of treatment at the established RP2D.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date August 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female subjects 18 years of age or older at the time of signing the informed consent - Subjects who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry - Subjects with a histologically confirmed, high-grade Ta or CIS (including CIS with concomitant Ta) urothelial cell carcinoma of the bladder according to central review - Subjects who are treatment naïve, 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 Exclusion Criteria: - Penicillin allergy (subjects with a questionable history of allergy to penicillin or no history of penicillin use will undergo penicillin allergy testing prior to inclusion in the study) - Predominant (defined as > 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components according to central review - Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment - Nodal involvement or metastatic disease that existed at any time (past or present disease) - Bladder cancer stage = T1 within the last 36 months according to central histology review - Bladder cancer stage CIS with concomitant T1 For more information on eligibility criteria, please contact the sponsor.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
TARA-002
Phase 1b, Dose Expansion Phase: All subjects will receive 6 weekly doses of TARA-002 at the recommended Phase 2 dose (R2PD)

Locations

Country Name City State
United States Chesapeake Urology Research Associates Baltimore Maryland
United States Mayo Clinic Jacksonville Florida
United States USC Norris Cancer Center Los Angeles California
United States Carolina Urologic Research Center Myrtle Beach South Carolina
United States Urology Associates PC Nashville Tennessee
United States Tulane Medical Center (TMC) - Clinic/Outpatient Facility New Orleans Louisiana
United States Premier Medical Group of the Hudson Valley Poughkeepsie New York
United States Mayo Clinic Rochester Minnesota
United States University of Rochester, Department of Urology Rochester New York
United States UT Health San Antonio San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Protara Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1b, Dose Expansion Phase: Incidence of AEs in subjects with CIS NMIBC with active disease AE = adverse event Day 1 to Day 78
See also
  Status Clinical Trial Phase
Recruiting NCT04736394 - A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients Phase 3
Recruiting NCT05951179 - Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer Phase 2
Active, not recruiting NCT04943094 - Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy
Not yet recruiting NCT06227065 - Precise Neoadjuvant Chemoresection of Low Grade NMIBC Phase 2
Completed NCT02969109 - Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer
Completed NCT01458847 - Cis-urocanic Acid (Cis-UCA) in Patients With Primary or Recurrent Non-muscle Invasive Bladder Cancer Phase 1
Recruiting NCT03914794 - A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors Phase 2
Recruiting NCT05126472 - Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment Phase 1
Recruiting NCT04644835 - Low Energy Shock Wave Therapy and Non-Muscle Invasive Bladder Cancer N/A
Recruiting NCT06126796 - Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
Active, not recruiting NCT04100733 - Surveillance of High-grade Non-muscle Invasive Bladder Tumours Using the Xpert Bladder Cancer Monitor N/A
Recruiting NCT03560479 - A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer Phase 1/Phase 2
Terminated NCT01310803 - Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder Phase 3
Completed NCT03081858 - Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer Phase 1/Phase 2
Completed NCT04498702 - Study of Continuous APL-1202 Treatment in Subjects With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Relapsed From Intravesical Chemo/BCG Therapy Phase 2
Recruiting NCT05337397 - Outpatient Laser Ablation of Recurrent Non-muscle Invasive Bladder Cancer
Active, not recruiting NCT04490993 - Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients Phase 3
Recruiting NCT04859751 - Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer Phase 3
Recruiting NCT05672615 - Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Not yet recruiting NCT06245603 - A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer N/A