Trial Title:
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer
NCT ID:
NCT05951179
Condition:
Non-muscle Invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Conditions: Keywords:
Non-muscle invasive bladder Cancer
bladder cancer
high grade Ta
high grade NMIBC
carcinoma in situ
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
All participants will receive 6 weekly instillations of TARA-002 at the established RP2D
(First Treatment Period). Participants who are eligible for reinduction after the First
Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part
of the Second Treatment Period. Participants confirmed to have a complete response after
the First Treatment Period will receive 3 additional weekly doses of TARA-002
instillation as maintenance during the Second Treatment Period. All eligible participants
will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment
Period (maintenance) at Months 6, 9, 12, 15, and 18. Following the Third Treatment
Period, all participants will continue to the Follow up Period from Month 21 until Month
60.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
TARA-002
Description:
All participants will receive 6 weekly instillations of TARA-002 at the established RP2D
(First Treatment Period). Participants who are eligible for reinduction after the First
Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part
of the Second Treatment Period. Participants confirmed to have a complete response after
the First Treatment Period will receive 3 additional weekly doses of TARA-002
instillation as maintenance during the Second Treatment Period. All eligible participants
will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment
Period (maintenance) at Months 6, 9, 12, 15, and 18. Following the Third Treatment
Period, all participants will continue to the Follow up Period from Month 21 until Month
60.
Arm group label:
TARA-002
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)
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Urology Group of Southern California
Address:
City:
Los Angeles
Zip:
90017
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
University of California Irvine Medical Center
Address:
City:
Orange
Zip:
92697
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Urology Associates of Denver
Address:
City:
Lone Tree
Zip:
80124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Southern Urology
Address:
City:
Lafayette
Zip:
70508
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
AccuMed Research Associates
Address:
City:
Garden City
Zip:
11530
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
University of Rochester, Department of Urology
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Carolina Urologic Research Center
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Conrad Person Clinic
Address:
City:
Memphis
Zip:
38128
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Urology Associates PC
Address:
City:
Nashville
Zip:
37209
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Urology Austin, LLC
Address:
City:
Austin
Zip:
78745
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Clinical Trial Network
Address:
City:
Houston
Zip:
77074
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Virginia Urology
Address:
City:
Richmond
Zip:
23235
Country:
United States
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Exdeo Clinical Research Inc
Address:
City:
Abbotsford
Zip:
V2T 1X8
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Jonathan Giddes Medicine Professional Corporation
Address:
City:
Brampton
Zip:
L6T 4S5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Facility:
Name:
Arensia Kapitanivka - PPDS
Address:
City:
Kapitanivka
Zip:
08111
Country:
Ukraine
Status:
Recruiting
Contact:
Last name:
Use Central Contact
Start date:
September 15, 2023
Completion date:
August 2030
Lead sponsor:
Agency:
Protara Therapeutics
Agency class:
Industry
Source:
Protara Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05951179
