A Multi-center, Open-label, Single Arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 30
- 主要终点
- MTD(Max tolerance does)
研究概览
简要总结
This study is a Multi-center, Open-label, single arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety , Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.
详细描述
This study includes Phase Ia and Phase Ib.
In the dose climbing part of phase Ia, the safety, tolerance and pharmacokinetics characteristics of CYH33 in patients with advanced solid tumors who failed to receive standard treatment, did not tolerate or did not have standard treatment at present will be observed to determine MTD; Before determining MTD, select safe and highly reliable and effective dose levels for simultaneous expansion. Phase Ia dose expansion includes patients with advanced solid tumors who have failed to undergo standard treatment, who are intolerant of PIK3CA gene mutation, or who do not have standard treatment at present, to further evaluate safety, tolerance and initial efficacy.
In Phase Ib, the safety and preliminary efficacy of CYH33 on patients with advanced breast cancer, ovarian cancer, endometrial cancer, cervical cancer, head and neck squamous cell carcinoma, esophageal and gastroesophageal junction squamous cell carcinoma, ovarian clear cell carcinoma and other solid tumors with PIK3CA gene mutation who have failed, are intolerant or do not have standard treatment at present will be evaluated.
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
- •main inclusion:
- •Evidence of a personally signed informed consent document;
- •Male and/or female subjects above the ages of 18 years;
- •Locally advanced or metastatic solid tumor patients who have failed or relapsed on current standard of care for Phase 1a;
- •Subject may provide Tumor tissue section(at least 8 pieces) if they agree;
- •ECOG performance score 0-1;
- •Life expectancy ≥ 12 weeks;
- •At least 1 measurable target lesion on the baseline scan as per RECIST 1.1
排除标准
- •main criteria:
- •prior received anti-tumor treatment, including anticancer drugs for the treatment within 28 days of first dose of study treatment;
- •Prior or concomitant other malignant tumor;
研究组 & 干预措施
Dose escalation study of CYH33
To determine the maximum tolerated dose (MTD) of CYH33
干预措施: CYH33 for tablet (Drug)
结局指标
主要结局
MTD(Max tolerance does)
时间窗: 35 days
To evaluate the MTD in patients with advanced solid tumor
次要结局
未报告次要终点