NCT06315491终止2 期
A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
Cybrexa Therapeutics18 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 18
- 主要终点
- Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125 mg/m2 every 21 days or 100 mg/m2 every 21 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histologically- or cytologically-diagnosed epithelial high-grade serous cancer of the ovary, fallopian tube cancer or primary peritoneum cancer that is refractory to prior therapy and must have platinum-resistant disease defined as:
- •Subjects who have received only 1 platinum-based chemotherapy regimen for at least 4 cycles of platinum must have disease progression on treatment or occurring ≤ 26 weeks after their last dose of platinum.
- •Patients who have progressed following a second course of a platinum based regimen.
- •Subjects may have up to 2 additional systemic regimens for advanced or metastatic disease. Maintenance regimens (e.g., with a PARP inhibitor or bevacizumab) are not considered separate regimens.
- •Age greater than or equal to 18 years at the time of signing the informed consent form (ICF).
- •Has measurable disease per RECIST 1.
- •Has provided written informed consent.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Adequate liver, renal, hematologic, pulmonary and coagulation function.
排除标准
- •Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy within 3 weeks prior to the first dose of CBX-
- •Subjects who are currently receiving any other anticancer or investigational agent(s).
- •Clinically significant intercurrent disease.
- •Active human immunodeficiency virus (HIV) infection.
- •Active hepatitis B or C infection.
研究组 & 干预措施
CBX-12 - 125mg/m2 q21d
Experimental
125mg/m2 CBX-12 administered by intravenous (IV) infusion every 21 days. Treatment will continue until there is evidence of progressive disease (PD) or development of unacceptable toxicity.
干预措施: CBX-12 (Drug)
CBX-12 - 100mg/m2 q21d
Experimental
100mg/m2 CBX-12 administered by intravenous (IV) infusion every 21 days. Treatment will continue until there is evidence of progressive disease (PD) or development of unacceptable toxicity.
干预措施: CBX-12 (Drug)
结局指标
主要结局
Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
时间窗: Randomization to progressive disease (PD) (Up to approximately 21 months)
ORR is defined as the proportion of subjects achieving a confirmed best overall response (BOR) of CR or PR defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
次要结局
- Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs)(First dose of study drug to 30-day post-dose follow up (Up to approximately 21 months))
- Median Duration of Response (DoR)(Date of Initial CR or PR to PD (Up to 21 Months))
- Progression-Free Survival (PFS)(Randomization to PD or Date of Death (Up to 21 Months))
- Plasma levels of CBX-12 (Cmax)(At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose)
- Plasma levels of CBX-12 (Tmax)(At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose)
- Plasma levels of CBX-12 (T1/2)(At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose)
- Plasma levels of Exatecan (Cmax)(At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose)
- Plasma levels of Exatecan (Tmax)(At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose)
- Plasma levels of Exatecan (T1/2)(At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose)
- Plasma levels of CBX-12 (AUC0-24hr)(At 1st dose of study drug (pre-dose, end of infusion (EOI), 1, 2, and 4 hours post EOI), and 10-14 days post 1st dose)
- Plasma levels of Exatecan (AUC0-24hr)(At 1st dose of study drug (pre-dose, end of infusion (EOI), 1 hour post EOI, 2 hours post EOI, 4 hours post EOI), and 10-14 days post 1st dose)
研究者
研究点 (18)
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