A Phase 1, First in Human Study of CTIM-76, a Claudin-6 (CLDN6)-Directed Bispecific Antibody, in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 25
- 主要终点
- Incidence of Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 (study drug), a CLDN6-directed T cell-engaging bispecific antibody , in participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).
详细描述
The phase 1a dose escalation portion of the trial will enroll participants with PRROC, testicular, or endometrial cancer into one of approximately 9 dose escalation cohorts to assess safety, tolerability and to determine the recommended dose for expansion (RDE). CTIM-76 is to be administered once according to the dose and schedule of the assigned cohort. Participants will be dosed until documentation of disease progression, unacceptable toxicity, or participant/physician decision.
The phase 1b dose expansion phase will first evaluate CTIM-76 in PRROC at minimum, 2 dose levels and/or dosing schedules will be evaluated (n=20 response evaluable participants in each cohort) in the dose expansion phase of the trial. . This is to enable dose- and exposure-response analyses. The expansion doses/dosing schedules for Phase 1b will be determined by Sponsor in conjunction with Safety Review Committee (SRC) based upon all available safety, pharmacokinetic (PK), pharmacodynamic (PD), biomarker and preliminary efficacy data from Phase 1a.
The selection of the RP2D will be based on the totality of data from Phase 1b.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Participants with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer.
- •Participants with measurable disease per RECIST 1.
- •ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks.
- •Participants with adequate organ function.
排除标准
- •Evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression.
- •Uncontrolled significant active infection or any medical or other condition that in opinion of the Investigator would preclude the participant's participation in the study.
- •Concurrent participation in another investigational clinical trial.
研究组 & 干预措施
CTIM-76
Phase 1a: Dose Escalation-each dose cohort will assess toxicity 28 days following the first dose of CTIM76; anticipate a total of 9 dose cohorts.
Phase 1b: Dose Expansion - approximately 80 participants will be evaluated at a minimum of 2 dose levels and/or dosing schedules of CTIM-76
干预措施: CTIM-76 (Drug)
结局指标
主要结局
Incidence of Dose Limiting Toxicities (DLTs)
时间窗: From date of first dose of CTIM-76 until 28 days following the first dose
Phase 1a will evaluate increasing doses of CTIM-76 based on the assessment of DLTs
Overall response rate (ORR)
时间窗: From date of first dose of CTIM-76 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
ORR will be based on the best overall response rate as assessed by Investigators according to RECIST v1.1
次要结局
未报告次要终点