Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

Official title

A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer

Overview

TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy 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 efficacy 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 (within 3 months) prior to signing the 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 who are BCG unresponsive

Interventions

• Biological TARA-002
  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

Primary outcome measures

• Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002 [Time frame: Month 3 to Month 60]

Secondary outcome measures (12)

• 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 [Time frame: Month 3 to Month 60]
• Cohort A and B: Duration of high-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002 [Time frame: Month 3 to Month 60]
• Cohort A and B: High-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002 [Time frame: Month 3 to Month 60]
• Cohort A and B: Duration of Complete Response (all recurrent bladder cancer, including low grade Ta) after treatment with TARA-002 [Time frame: Month 3 to Month 60]
• 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, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002 [Time frame: Month 3 to Month 60]
• Cohort A and B: Progression free survival after treatment with TARA-002 [Time frame: 60 months]
• Cohort A and B: Disease-specific progression free survival after treatment with TARA-002 [Time frame: 60 months]
• Cohort A and B: Overall survival after treatment with TARA-002 [Time frame: 60 months]
• Cohort A and B: Disease specific survival after treatment with TARA-002 [Time frame: 60 months]
• Cohort A and B: Time to cystectomy after treatment with TARA-002 [Time frame: 60 months]
• Cohort A and B: Time to recurrence delayed cystectomy after treatment with TARA-002 [Time frame: 60 months]
• Cohort A and B: Time to progression after treatment with TARA-002 [Time frame: 60 months]

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 CIS (± Ta/T1) who are BCG unresponsive.

Exclusion criteria

• Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
• Central confirmed variant histology
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 41 centers

• Urology Centers of Alabama — Homewood
• Mayo Clinic — Phoenix
• East Valley Urology Center of Arizona — Queen Creek
• Arkansas Urology — Little Rock
• Michael Oefelein Clinical Trials — Bakersfield
• Urology Group of Southern California — Los Angeles
• University of California Irvine Medical Center — Orange
• Genesis Research — San Diego
• … and 33 more centers

Japan · 10 centers

• Komaki City Hospital — Komaki-shi
• Japanese Red Cross Aichi Medical Center Nayoya Daiichi — Nagoya
• Fuji City General Hospital — Sakura-shi
• Kyushu University Hospital — Fukuoka
• Hyogo Prefectural Amagasaki General Medical Center — Amagasaki-shi
• Hitachi General Hospital — Hitachi-shi
• Niigata Cancer Center Hospital — Niigata
• Japanese Red Cross Osaka Hospital — Osaka
• … and 2 more centers

Brazil · 8 centers

• Kyushu University Hospital — Nova Lima
• Office of Lucas Nougeria MA — Nova Lima
• Santa Casa de Misericordia de Porto Alegre — Porto Alegre
• Nucleo de Pesquisa Clinica do Rio Grande so Sul — Porto Alegre
• Centro de Urologia Avancada — Porto Alegre
• Hospital de Clinicas da UNICAMP — Campinas
• Instituto Dor de Pesquisa e Ensino — Jardim Paulista
• Faculdade de Medicina ABC-CEPHO — Santo André

Argentina · 7 centers

• Hospital Italiano de Buenos Aires (HIBA) — Buenos Aires
• Hospital Britanico de Buenos Aires — Buenos Aires
• Centro Argentino de Urologia — CABA
• Hospital Sirio Libanes — CABA
• Centro Urologico Profesor Bengio SA — Córdoba
• CEMAIC — Córdoba
• Clinica Privada Independencia — Munro

Canada · 4 centers

• Exdeo Clinical Research Inc — Abbotsford British Columbia
• Jonathan Giddes Medicine Professional Corporation — Brampton
• Sunnybrook Research Institute — Toronto
• UHN Princess Margaret Cancer Centre Princess Margaret Hospital — Toronto

Ukraine · 1 center

• Arensia Kapitanivka - PPDS — Kapitanivka

Identifiers

NCT: NCT05951179 · TARA-002-101-Ph2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗