An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 121
- 试验地点
- 5
- 主要终点
- Determine the recommended Phase 2 dose (RP2D)
研究概览
简要总结
The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.
详细描述
The study is comprised of 2 parts. Part 1 involves CX-801 dose escalation to identify the maximum tolerated dose (MTD) of CX-801 as monotherapy and as combination therapy (CX-801 combined with pembrolizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-801 combination therapy in indication-specific expansion cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Measurable disease per RECIST v1.1
- •Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue
- •Adequate organ function
- •Additional inclusion criteria may apply
排除标准
- •Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated
- •Known active central nervous system (CNS) involvement by malignancy
- •Prior PD-1/ PD-(L)1 inhibitor treatment discontinued due to grade 3 or higher immune related adverse event
- •Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment
- •Investigational drug or device within 4 weeks prior to first dose of study treatment
- •Radiation within 2 weeks prior to first dose of study treatment
- •Serious concurrent illness
- •Pregnant or breast feeding
- •Additional exclusion criteria may apply
研究组 & 干预措施
CX-801
干预措施: CX-801 (Drug)
CX-801 + pembrolizumab
干预措施: CX-801 (Drug)
CX-801 + pembrolizumab
干预措施: pembrolizumab (Drug)
结局指标
主要结局
Determine the recommended Phase 2 dose (RP2D)
时间窗: 44 months
The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
Safety and tolerability of CX-801 as monotherapy and combination therapy
时间窗: 44 months
The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
次要结局
- Objective response rate (ORR)(60 months)
- Duration of response (DOR)(60 months)
- Progression-free survival (PFS)(60 months)
- Disease control rate (DCR)(60 months)
- Duration of disease control (DODC)(60 months)
- Overall survival (OS)(60 months)