A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APG-2449 Monotherapy or in Combination With Anticancer Agents in Patients With Platinum-resistant Recurrent Ovarian Cancer or Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Treatment-related adverse events per NCI-CTCAE version 5.0.
研究概览
简要总结
An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.
详细描述
Part A: To evaluate the safety of APG-2449 monotherapy in patients with advanced solid tumors.
Part B: To evaluate the safety, tolerability, and efficacy of APG-2449 combined with PLD in the treatment of ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Part A: No gender limitation. Patients with histologically and/or cytologically confirmed ALK/ROS1 gene fusion positive non-small cell lung cancer and various advanced tumors.
- •Part B: Female only. Histologically proven ovarian epithelial, fallopian tube, or primary peritoneal carcinoma.
- •At least one measurable tumor lesion.
- •ECOG score is 0~
- •Life expectancy of ≥3 months.
- •AE caused by previous treatment must recover to ≤ grade
- •Sufficient bone marrow, liver, kidney and coagulation function.
- •Female patients must be in a non-pregnant and non-lactating state.
- •Able to understand and willing to sign informed consent.
- •Patients are required to provide fresh or archived tumor tissue samples prior to treatment.
排除标准
- •Undergone major surgery or major trauma within 28 days before first dose or a diagnostic biopsy within 14 days before first dose.
- •Received systemic antitumor drugs, including investigational drugs.
- •Received radiotherapy within 14 days before first dose.
- •Previous treatment with FAK inhibitors.
- •Have tumors at positions other than existing ovarian cancer or of other histological types within 3 years before first dose.
- •Known active central nervous system (CNS) metastases and/or cancerous meningitis.
- •Major cardiovascular and cerebrovascular disease occurred within 6 months before first dose.
- •Patients with pleural effusion, pericardial effusion, or ascites requiring puncture, drainage, or having received drainage within 1 month before first dose.
- •Malabsorption syndrome, or inability to take medications orally.
- •Severe gastrointestinal disease.
- •Any serious or uncontrolled systemic disease; Various chronic active infections.
- •Allergy to APG-2449 or PLD and its drug components.
- •Previous cumulative doses of anthracyclines ≥550 mg/m^
- •Patients using a moderately potent CYP3A4, CYP2C9, or CYP2C19 inhibitor/inducer or P-gp inhibitor within a week before first dose. Patients using CYP3A4 substrates and the drugs of a narrow treatment window within a week before first dose.
- •Other factors that, in the investigator's judgment, should prevent the patient from entering the study.
研究组 & 干预措施
APG -2449 combined with PLD
Part B: Dose exploration and expansion of APG-2449 combined PLD.
干预措施: APG -2449 (Drug)
APG -2449 Monotherapy
Part A: Monotherapy for advanced solid tumors.
干预措施: APG -2449 (Drug)
APG -2449 combined with PLD
Part B: Dose exploration and expansion of APG-2449 combined PLD.
干预措施: PLD (Drug)
结局指标
主要结局
Treatment-related adverse events per NCI-CTCAE version 5.0.
时间窗: Up to 1 year
The number and frequency of adverse events of test drug will be assessed according to CTCAE v5.0.
Dose Limiting Toxicity(DLT).
时间窗: Up to 28 days
DLT will be defined based on the rate of drug-related grade 3 to 5 adverse events experienced within the first 4 weeks of study treatment. These will be assessed per NCI-CTCAE version 5.0.
次要结局
未报告次要终点