A Phase 1a/1b, First Time in Human Study of CT-202, A Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, and Urothelial Cancers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 7
- 主要终点
- Phase 1a: Incidence of Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This is a Phase 1a/1b, first time in human (FTIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, and preliminary efficacy of CT-202 (study drug), a humanized T cell engaging bispecific antibody targeting nectin-4, in participants with nectin-4 expressing recurrent, unresectable or metastatic refractory/resistant TNBC, CRC, or UC. Results of the study including PK, PD, efficacy, and safety will be used in the RP2D determination.
详细描述
Phase 1a Dose Escalation: Will follow a Bayesian Optimal Interval (BOIN) design (Liu, 2015) with step up dosing (i.e. priming followed by full doses of CT-202), Q2W administration schedule, and approximately 6 dose levels. Participants will continue study treatment until confirmed disease progression, the occurrence of unacceptable toxicity, withdrawal from the study or decision to discontinue treatment by the investigator.
Phase 1b Dose Expansion: Upon completion of the dose escalation Phase 1a, CT-202 may be evaluated at 2 or more dose levels and 2 or more dosing schedules in at least 4 but up to 6 expansion cohorts. The population(s) will include participants with the same tumor indications, or subsets, evaluated in the dose escalation phase (TNBC, CRC, or UC). Up to 15 participants will be assigned to each dosing cohort.
Based on the totality of data from Phase 1b, a RP2D for future clinical studies will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Participants with nectin-4-positive triple negative breast cancer, colorectal cancer, or urothelial cancer that have received standard therapies
- •Participants with measurable disease per RECIST 1.1
- •ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks
- •Participants have adequate organ function.
排除标准
- •History of severe skin toxicity
- •Uncontrolled significant active infection or any medical or other condition that in the 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
Phase 1b
Phase 1b: Dose Expansion - participants will be evaluated in 4-6 cohorts at different doses and schedules of CT-202
干预措施: CT-202 (Drug)
Phase 1a
Dose Escalation-Bayesian Optimal Interval (BOIN) Design with approximately 54 patients in dose escalation.
干预措施: CT-202 (Drug)
结局指标
主要结局
Phase 1a: Incidence of Dose Limiting Toxicities (DLTs)
时间窗: From date of first dose of CT-202 until 28 days following the first dose
Phase 1a will evaluate increasing doses of CT-202 based on the assessment of DLTs
Phase 1b: Overall response rate (ORR)
时间窗: From date of first dose of CT-202until 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 overall response rate as assessed by Investigators according to RECIST v1.1
次要结局
未报告次要终点