CTIS2023-505062-28-00进行中（未招募）1 期
A Phase 1b/2, dose expansion, open-label study to evaluate safety and anti-tumor activity of intravesical instillation of TARA-002 in adults with high-grade non-muscle invasive bladder cancer. - TARA-002-101-Ph1b/2
Protara Therapeutics Inc.0 个研究点目标入组 102 人开始时间: 2023年6月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Male or female subjects 18 years of age or older at the time of signing the informed consent, 10. If sexually active with female partners, the sexually mature, nonsterile male agrees to use a medically acceptable method of contraception and abstains from donating sperm for the duration of the study and for at least 4 weeks after the last dose of investigational product. Males are considered surgically sterile if they have undergone bilateral orchiectomy or vasectomy at least 12 weeks prior to signing informed consent. Acceptable methods of contraception include: a. The simultaneous use of stable hormonal contraception by the female partner in conjunction with a double-barrier method (e.g., condom with spermicide or diaphragm with spermicide), or; b. The female partner’s use of an intrauterine device in place for at least 12 weeks, in conjunction with a double barrier method, or; c. The female partner is surgically sterile for at least 6 weeks or is at least 12 months postmenopausal, or; d. Abstinence if this is the subject’s usual lifestyle and preferred contraception, 11. Females of childbearing age with a negative pregnancy test per local read, 12. Subjects whose treating physician must confirm availability and access to TARA-002, 13. Subjects who have not completed vaccination against COVID-19 should be negative for COVID-19 infection (according to local site requirements, e.g., rapid test, polymerase chain reaction [PCR] within the 42-day screening window PRIOR to receiving their first dose of TARA-002 at Treatment Day 1). Results can be read and interpreted locally., 2. 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, 3. Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease a. CIS with active disease is defined as CIS (± Ta/T1) present on last tumor evaluation prior to signing ICF. The specimen containing CIS should be submitted for central review to determine eligibility. If re-staging TURBT was performed prior to signing informed consent, CIS with active disease may be determined from ANY specimen during this tumor evaluation period (i.e., staging or re-staging). b. Subjects with CIS + T1 without muscle in specimen should undergo re-staging TURBT to confirm eligibility (e.g., absence of muscle invasion). If re-staging was not completed prior to signing ICF, re-staging cystoscopy/cytology/TURBT can be performed in the same setting during screening. Local interpretation of restaging is acceptable to confirm eligibility. Study visits may be delayed by up to 28 days after TURBT/biopsy procedure only if required per the site’s standard of care. c. All papillary disease should be completely resected prior to dosing. d. If there is discrepancy for inclusion/exclusion between local pathology and central pathology, please contact the sponsor for guidance., 4. Cohort A only: Subjects with CIS (± Ta/T1) who are unable to obtain intravesical BCG or have not received intravesical BCG for 24 months prior to CIS diagnosis a. Inability to access BCG may include, but is not limited to, medical reasons or shortage-related reasons b. Inability to access BCG due to affordability-related reasons is not permitted, 5. Cohort B only: BCG unresponsive CIS a. Persistent or recurrent CIS (± Ta/T1) within 12 months of completion of adequate BCG (at least 5 of 6 doses of an initial induction
排除标准
- •1. Penicillin allergy (subjects with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory. If penicillin blood allergy test is negative, subject is eligible for the study)., 10. Concurrent or planned biologic therapy, hormonal therapy (other than oral contraception), chemotherapy, surgery (other than TURBT and/or biopsy), or other cancer therapy during study period. Note: concurrent or planned hormonal therapy refers to hormone treatment for cancer or immunosuppression, and does not refer to routine medications for chronic disease e.g. diabetes, hypothyroidism, osteoporosis, 11. Concurrent malignancy diagnosed within 6 months prior to the time of signing the informed consent. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer, or low or very low risk prostate cancer. Note: history of prior malignancy is allowed so long as it is not concurrent or is stable for more than 6 months per the Investigator’s assessment, 12. Receipt of any other anti-cancer therapy (including investigational agents) within 6 weeks prior to signing informed consent. Subjects who enrolled in any investigational treatment studies and received investigational therapies for high-grade NMIBC are excluded., 13. Inadequate organ and bone marrow function based on central laboratory defined as: a. Hemoglobin = 8.0g/dL b. Absolute neutrophil count = 1.5 x 109 / L c. Platelet count = 80 x 109 / L d. Aspartate aminotransferase (AST)/aspartate transaminase (SGOT) and/or alanine aminotransferase (ALT)/alanine transaminase (SGPT) = 2.5 x upper limit of normal (ULN) e. Total bilirubin >1.0 x ULN f. Creatinine Clearance < 30 mL/min (as calculated by central laboratory), 14. Current indwelling ureteral stent. If stent is anticipated to be removed prior to drug administration, this is allowed, 15. A woman who is nursing, pregnant, or intending to become pregnant during the study period, 16. Known human immunodeficiency (HIV) infection or other immunodeficiency disorders, either primary or acquired. Exceptions include subjects requiring use of inhaled or intranasal corticosteroids or local steroid injections, 17. In the opinion of the treating Investigator, the subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, 2. Central histologic review, predominant (defined as > 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components (Note: If predominant histology is urothelial, the subject is eligible for the study). Subjects with any micropapillary component will be excluded., 3. Concomitant prostatic or upper tract urothelial involvement per Investigator’s assessment a. Prior history of prostatic and upper tract disease is acceptable as long as there is no disease in these areas at the time of dosing, 4. Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past). The determination of nodal and metastatic disease is determined by the Investigator after reviewing local imaging results. Note: A diagnosis of nodal and metastatic disease is not solely based on radiographic imaging,
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