NCT05951179招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 131
- 试验地点
- 120
- 主要终点
- Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
TARA-002
Experimental
TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain.
干预措施: TARA-002 (Biological)
结局指标
主要结局
Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002
时间窗: Month 3 to Month 60
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
时间窗: Month 3 to Month 60
次要结局
- Cohort A and B: Incidence and severity of AEs, TEAEs, SAEs and TESAEs after treatment with TARA-002(Day 1 to Month 60)
- 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(Day 1 to Day 72)
- Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-NMIBC24(Day 1 to Month 24)
- Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-C30(Day 1 to Month 24)
- Cohort A and B: Progression free survival after treatment with TARA-002(60 months)
- Cohort A and B: Disease-specific progression free survival after treatment with TARA-002(60 months)
- Cohort A and B: Overall survival after treatment with TARA-002(60 months)
- Cohort A and B: Disease specific survival after treatment with TARA-002(60 months)
- Cohort A and B: Time to cystectomy after treatment with TARA-002(60 months)
- Cohort A and B: Time to recurrence delayed cystectomy after treatment with TARA-002(60 months)
- Cohort A and B: Time to progression after treatment with TARA-002(60 months)
- Cohort A and B: Time to disease worsening after treatment with TARA-002(60 months)
- 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(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(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(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(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(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(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(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(Month 3 to Month 60)
- Cohort A and B: Progression free survival after treatment with TARA-002(60 months)
- Cohort A and B: Disease-specific progression free survival after treatment with TARA-002(60 months)
- Cohort A and B: Overall survival after treatment with TARA-002(60 months)
- Cohort A and B: Disease specific survival after treatment with TARA-002(60 months)
- Cohort A and B: Time to cystectomy after treatment with TARA-002(60 months)
- Cohort A and B: Time to recurrence delayed cystectomy after treatment with TARA-002(60 months)
- Cohort A and B: Time to progression after treatment with TARA-002(60 months)
- Cohort A and B: Time to disease worsening after treatment with TARA-002(60 months)
- Cohort A and B: Incidence and severity of AEs, TEAEs, SAEs and TESAEs after treatment with TARA-002(Day 1 to Month 60)
- 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(Day 1 to Day 72)
- Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-NMIBC24(Day 1 to Month 24)
- Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-C30(Day 1 to Month 24)
研究者
研究点 (120)
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相关资讯
Protara's TARA-002 Cell Therapy Achieves 72% Complete Response Rate in BCG-Naïve Bladder Cancer Patients- Protara's TARA-002 cell therapy demonstrated a 72% complete response rate in BCG-naïve non-muscle invasive bladder cancer patients during the Phase II ADVANCED-2 trial.
- The therapy maintained durable responses with 69% complete response at six months and 50% at 12 months, while showing favorable tolerability with mostly Grade 1 adverse events.
- If approved, TARA-002 would become the first drug to receive regulatory approval for BCG-naïve NMIBC since BCG itself was introduced decades ago.
- Protara's stock increased 9% following the announcement, and analysts forecast the drug could generate $62 million in its first year and $452 million by 2031.9 months agoProtara Therapeutics to Present Phase 2 TARA-002 Data for BCG-Naïve Bladder Cancer Patients at SUO Meeting- Protara Therapeutics will present interim data from 31 BCG-naïve non-muscle invasive bladder cancer patients treated with TARA-002 at the Society of Urologic Oncology meeting in December 2025.
- The Phase 2 ADVANCED-2 trial evaluates intravesical TARA-002 in patients with carcinoma in situ, with the majority of enrolled patients having reached the six-month evaluation timepoint.
- TARA-002 is an investigational cell therapy derived from Streptococcus pyogenes that activates immune responses and directly kills tumor cells through immunogenic cell death.
- Non-muscle invasive bladder cancer represents approximately 80% of bladder cancer diagnoses, affecting about 65,000 patients annually in the United States.10 months agoProtara Therapeutics Presents Promising Interim Data on TARA-002 for Bladder Cancer- Protara Therapeutics is presenting interim Phase 2 data for TARA-002 in non-muscle invasive bladder cancer (NMIBC) at the SUO annual meeting.
- The ADVANCED-2 trial evaluates TARA-002 in BCG-unresponsive and BCG-naïve NMIBC patients, with a focus on carcinoma in situ.
- TARA-002, derived from the same cell bank as OK-432, aims to stimulate an immune response against bladder cancer cells.
- Interim data includes safety and efficacy results from approximately 20 patients, with the majority being six-month evaluable.last year