Clinical trial NCT05085977: Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1a)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-muscle Invasive Bladder Cancer
Keywords: Non-muscle invasive bladder cancer
bladder cancer
high grade Ta
carcinoma in situ
high-grade NMIBC
Lead sponsor: Protara Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-10-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: First, up to 3 dose levels of TARA-002 (10 KE → 20 KE → 40 KE) will be tested sequentially with 6 weekly intravesical doses starting with the lowest dose using a 3+3 design in a dose escalation manner until the RP2D has been established. If the MTD is not reached, additional cohorts of dose levels higher than 40 KE may be explored.
Primary purpose: TREATMENT

Brief summary: This study is an open-label dose escalation study (Phase 1a) 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. Dosing will start in subjects with HGTa or CIS (including CIS with concomitant Ta), and all subjects will receive 6 weeks of treatment at a fixed volume with varying dose levels.


Eligibility criteria: 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 on central review
* 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

Exclusion Criteria:

* Penicillin allergy (subjects with a questionable history of allergy to penicillin or no history of penicillin use will undergo penicillin blood 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.

Primary outcomes:
measure: Phase 1a, Dose Escalation Phase: Incidence of DLT AEs in subjects with HGTa or CIS NMIBC
timeFrame: Day 1 to Day 43
measure: Phase 1a, Dose Escalation Phase: MTD and RP2D of TARA-002 in subjects with HGTa or CIS NMIBC
timeFrame: Day 1 to Day 43
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Cancer Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Mount Laurel
country: United States
facility: New Jersey Urology
state: New Jersey
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Rochester
country: United States
facility: University of Rochester, Department of Urology
state: New York
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates PC
state: Tennessee
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: Chisinau
country: Moldova, Republic of
facility: PMSI Republican Clinical Hospital "T. Mosneaga," ARENSIA Exploratory Medicine Phase I Unit
city: Bucharest
country: Romania
facility: Spitalul Clinic de Nefrologie Carol Davila
city: Kapitanivka
country: Ukraine
facility: Arensia Kapitanivka
Study officials:
affiliation: Protara Therapeutics
name: Chief Scientific Operations Officer
role: STUDY_DIRECTOR
References: