Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 9
- 主要终点
- Determine the MTD or RD of CT-95 [Safety and Tolerability]
研究概览
简要总结
This is a Phase 1a/1b, first-in-human (FIH), open-label, multi-center dose escalation and expansion study of the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of single-agent CT-95 in subjects with advanced (recurrent, unresectable, or metastatic) cancers associated with MSLN expression.
详细描述
Phase 1a Dose Escalation: Participants with ovarian epithelial tumors, primary peritoneal or fallopian tube cancer (PROC), epithelioid mesothelioma, lung adenocarcinoma, pancreatic adenocarcinoma, colorectal cancer, cholangiocarcinoma, and gastric/GEJ adenocarcinomas will be enrolled in one of approximately 9 dose escalation cohorts to assess the safety and tolerability of CT-95, as well as determine the maximum tolerated dose (MTD) or other recommended dose(s) for expansion (RDE[s]) for further dose expansion cohorts.
Participants will receive CT-95 as a single agent administered once weekly (QW) intravenously (IV) over a 4-week cycle.
Phase 1b Dose Expansion: The RDE(s) of CT-95 determined in Phase 1a will be evaluated in 2-4 indication-specific expansion cohorts of up to 20 subjects each (i.e. up to 80 participants total). Different indications, dose levels, and/or schedules may be explored. The expansion doses and/or dosing schedules for Phase 1b will be determined by Sponsor in conjunction with SRC based upon all available safety, PK, PD, biomarker, and preliminary efficacy data from Phase 1a.
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
- •ECOG 0 or 1
- •Subjects with evaluable disease per RECIST 1.1 or mRECIST
- •Subjects with adequate organ function.
- •Subjects with advanced cancers associated with mesothelin expression
排除标准
- •Uncontrolled significant active infection or any medical or other condition that in opinion of the investigator would preclude the subject's participation in the study.
- •Prior treatment with MSLN-targeted CD3 or chimeric antigen receptor T cell (CAR-T) therapy
- •Concurrent participation in another investigational clinical trial.
- •Evidence of leptomeningeal disease
研究组 & 干预措施
CT-95
Each dose cohort will have weekly dosing. Anticipate approximately 8 dose cohorts.
干预措施: CT-95 (Drug)
结局指标
主要结局
Determine the MTD or RD of CT-95 [Safety and Tolerability]
时间窗: From date of first dose of CT-95 until 28 days following the first dose.
The frequency of dose-limiting toxicities (DLTs) will be analyzed along with safety and tolerability measures to determine the MTD or RD of CT-95.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.
The frequency and severity of adverse events, serious adverse events, and adverse events of special interest will be analyzed.
次要结局
- Evaluate Response Rates [Anti-tumor Activity](At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first)
- Evaluate Progression-free Survival [Anti-tumor Activity](At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.)
- Evaluate Overall Survival [Survival](From the time of the first dose of CT-95 until approximately two years post-first dose.)
- Evaluate the Maximum Serum Concentration (Cmax) [Pharmacokinetics](From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.)
- Evaluate the Area Under the Curve (AUC) [Pharmacokinetics](From date of first dose of CT-95 for 5 months or treatment discontinuation, whichever comes first.)
- Evaluate Anti-Drug Antibodies [Immunogenicity](From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.)