Brief Summary
TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).
The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).
This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF).
Participants will be enrolled into one of 2 cohorts:
Cohort A:
* Participants with CIS (± Ta/T1) who are BCG naive, or
* Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis
Cohort B:
* Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)
The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).
This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF).
Participants will be enrolled into one of 2 cohorts:
Cohort A:
* Participants with CIS (± Ta/T1) who are BCG naive, or
* Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis
Cohort B:
* Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)
Brief Title
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
16468440337
Central Contact Email
clinicaltrials@protaratx.com
Completion Date
Completion Date Type
Estimated
Conditions
Non-muscle Invasive Bladder Cancer
Eligibility Criteria
Inclusion Criteria:
* Male or female participants 18 years of age or older at the time of signing informed consent
* Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
* Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
* Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (Cohort B).
Exclusion Criteria:
* Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
* 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 and metastatic disease are excluded if they existed at any time (whether present or in the past)
* Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history
For more information on eligibility criteria, please contact the Sponsor
* Male or female participants 18 years of age or older at the time of signing informed consent
* Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
* Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
* Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (Cohort B).
Exclusion Criteria:
* Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
* 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 and metastatic disease are excluded if they existed at any time (whether present or in the past)
* Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history
For more information on eligibility criteria, please contact the Sponsor
Inclusion Criteria
Inclusion Criteria:
* Male or female participants 18 years of age or older at the time of signing informed consent
* Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
* Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
* Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (Cohort B).
* Male or female participants 18 years of age or older at the time of signing informed consent
* Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
* Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
* Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (Cohort B).
Gender
All
Gender Based
false
Keywords
Non-muscle invasive bladder Cancer
bladder cancer
high grade Ta
high grade NMIBC
carcinoma in situ
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05951179
Org Class
Industry
Org Full Name
Protara Therapeutics
Org Study Id
TARA-002-101-Ph2
Overall Status
Recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 2, Open-Label Study to Evaluate the Safety and Anti-Tumor Activity of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer
Primary Outcomes
Outcome Measure
Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002
Outcome Time Frame
Month 3 to Month 60
Outcome Measure
Cohort A: Incidence of high-grade Complete Response at any time by subgroup (BCG naive and BCG exposed > 24 months) according to central pathology after treatment with TARA-002
Outcome Time Frame
Month 3 to Month 60
Secondary Outcomes
Outcome Time Frame
Month 3 to Month 60
Outcome Measure
Cohort A and B: Duration of high-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
Outcome Time Frame
Month 3 to Month 60
Outcome Measure
Cohort A and B: High-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
Outcome Time Frame
Month 3 to Month 60
Outcome Measure
Cohort A and B: Duration of Complete Response (all recurrent bladder cancer, including low grade Ta) after treatment with TARA-002
Outcome Time Frame
Month 3 to Month 60
Outcome Measure
Cohort A and B: Complete Response rate (all recurrent bladder cancer, including low grade Ta) at Months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
Outcome Time Frame
60 months
Outcome Measure
Cohort A and B: Progression free survival after treatment with TARA-002
Outcome Time Frame
60 months
Outcome Measure
Cohort A and B: Disease-specific progression free survival after treatment with TARA-002
Outcome Time Frame
60 months
Outcome Measure
Cohort A and B: Overall survival after treatment with TARA-002
Outcome Time Frame
60 months
Outcome Measure
Cohort A and B: Disease specific survival after treatment with TARA-002
Outcome Time Frame
60 months
Outcome Measure
Cohort A and B: Time to cystectomy after treatment with TARA-002
Outcome Time Frame
60 months
Outcome Measure
Cohort A and B: Time to recurrence delayed cystectomy after treatment with TARA-002
Outcome Time Frame
60 months
Outcome Measure
Cohort A and B: Time to progression after treatment with TARA-002
Outcome Time Frame
60 months
Outcome Measure
Cohort A and B: Time to disease worsening after treatment with TARA-002
Outcome Description
AE = adverse event; TEAE = treatment emergent adverse event; SAE = serious adverse event; TESAE = treatment emergent serious adverse event
Outcome Time Frame
Day 1 to Month 60
Outcome Measure
Cohort A and B: Incidence and severity of AEs, TEAEs, SAEs and TESAEs after treatment with TARA-002
Outcome Time Frame
Day 1 to Day 72
Outcome Measure
Cohort A and B: Change from baseline in urine pharmacodynamic biomarker levels (including IL-6, IL-8, IFN-γ, and TNF-α) after treatment with TARA-002
Outcome Description
EORTC = European Organization for Research and Treatment of Cancer; QLQ-NMIBC24 = Questionnaire for Patients with NMIBC
Outcome Time Frame
Day 1 to Month 24
Outcome Measure
Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-NMIBC24
Outcome Description
EORTC = European Organization for Research and Treatment of Cancer; QLQ-C30 = Questionnaire for Patients with Cancer
Outcome Time Frame
Day 1 to Month 24
Outcome Measure
Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-C30
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alexander Sankin
Investigator Email
asankin@montefiore.org