jRCT2031240255招募中不适用
An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 17
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Module 1 Part A1 and Module 2 Part A1: Locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator
- •Eastern Cooperative Oncology Group Performance Status less than or equal to (<=) 1
- •Life expectancy of more than 6 months
- •Have adequate hematologic function
- •Participants who received chemotherapy, extensive radiotherapy, biological therapy (e.g. antibodies) or investigational agents will have a washout period of 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives whichever is shorter, prior to starting study intervention with M9466 (+- tuvusertib)
- •Module 3 Part A1:
- •Histologically or pathologically confirmed diagnosis of prostate cancer
- •Metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI.
- •Participants with mCRPC or mHSPC are allowed. For mCRPC, serum testosterone levels <= 50 /dL (<= 1.75 nmol/L).
- •Ongoing ADT with a GnRH agonist or antagonist for participants who have not undergone bilateral orchiectomy must be initiated before first dose and must continue throughout the study.
- •Candidate for treatment with abiraterone acetate.
- •Prior anticancer therapy allowed for mHSPC or mCRPC
- •Other protocol defined inclusion criteria could apply
排除标准
- •Persistence of Adverse Events related to any prior treatments that have not recovered to Grade less than 1 by NCI Common Terminology Criteria for Adverse Events- v5.0 unless AEs are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator (e.g. neuropathy or alopecia)
- •Participant has a history of malignancy within 5 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)
- •Participants with known brain metastases, except if clinically controlled, which is defined as individuals with Central Nervous System (CNS) tumors that have been treated, are asymptomatic and who have discontinued steroids (for the treatment of CNS tumors) for more than 28 days
- •Serious Gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease (including exocrine pancreatic insufficiency requiring pancreatic enzyme replacement therapy), and/or other situations that may preclude adequate absorption of oral medications
- •Cerebrovascular accident or stroke
- •Module 3 only:
- •Current evidence of any of the following:
- •a. Any medical condition that would make prednisone (or equivalent) use contraindicated.
- •b. Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone (or equivalent) once daily.
- •History of uncontrolled pituitary or adrenal dysfunction
- •Hypokalemia
- •Other protocol defined exclusion criteria could apply
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs
Module 3 Part A1
Number of Participants with Dose Limiting Toxicity (DLT)-like events
Module 3 Part A1
Pharmacokinetic (PK) Plasma Concentrations of M9466
Module 2 Part A1
次要结局
未报告次要终点
研究者
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