Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer (ADVANCED-1)
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| ClinicalTrials.gov Identifier: NCT05085990 |
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Recruitment Status :
Recruiting
First Posted : October 20, 2021
Last Update Posted : May 3, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-muscle Invasive Bladder Cancer | Biological: TARA-002 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 12 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | All subjects will receive 6 weekly doses of TARA-002 at the recommended Phase 2 dose (R2PD) |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1a/b Dose Finding, Open-label Study to Evaluate Safety and Toxicity of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer |
| Actual Study Start Date : | May 8, 2023 |
| Estimated Primary Completion Date : | June 2024 |
| Estimated Study Completion Date : | August 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: TARA-002
TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin.
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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) |
- Phase 1b, Dose Expansion Phase: Incidence of AEs in subjects with CIS NMIBC with active disease [ Time Frame: Day 1 to Day 78 ]AE = adverse event
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085990
| Contact: Chief Scientific Operations Officer | 16468440337 | clinicaltrials@protaratx.com |
| United States, California | |
| USC Norris Cancer Center | Recruiting |
| Los Angeles, California, United States, 90089 | |
| Contact: Use Central Contact | |
| United States, Florida | |
| Mayo Clinic | Active, not recruiting |
| Jacksonville, Florida, United States, 32224 | |
| United States, Louisiana | |
| Tulane Medical Center (TMC) - Clinic/Outpatient Facility | Active, not recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Chesapeake Urology Research Associates | Completed |
| Baltimore, Maryland, United States, 21204 | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Use Central Contact | |
| United States, New York | |
| Premier Medical Group of the Hudson Valley | Completed |
| Poughkeepsie, New York, United States, 12603 | |
| University of Rochester, Department of Urology | Active, not recruiting |
| Rochester, New York, United States, 14642 | |
| United States, South Carolina | |
| Carolina Urologic Research Center | Active, not recruiting |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Tennessee | |
| Urology Associates PC | Active, not recruiting |
| Nashville, Tennessee, United States, 37209 | |
| United States, Texas | |
| UT Health San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Use Central Contact | |
| Study Director: | Chief Scientific Operations Officer | Protara Therapeutics |
| Responsible Party: | Protara Therapeutics |
| ClinicalTrials.gov Identifier: | NCT05085990 |
| Other Study ID Numbers: |
TARA-002-101(Phase 1b) |
| First Posted: | October 20, 2021 Key Record Dates |
| Last Update Posted: | May 3, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Non-muscle invasive bladder cancer bladder cancer high grade Ta carcinoma in situ high-grade NMIBC |
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Urinary Bladder Neoplasms Non-Muscle Invasive Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Urinary Bladder Diseases Urologic Diseases Male Urogenital Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |