A Phase 1/1b, Open-label, Dose-finding, First-in-human Study to Evaluate the Safety and Antitumor Activity of CX-904, an EGFR-targeted T-cell Engager in Advanced Solid Tumors (CTMX-904-101)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 83
- 试验地点
- 5
- 主要终点
- Patients Experiencing Dose-limiting Toxicity
研究概览
简要总结
The purpose of this first-in-human study, CTMX-904-101, is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-904 in adult subjects with metastatic or locally advanced unresectable solid tumors.
详细描述
This is a first-in-human study evaluating the safety, tolerability, and activity of CX-904, a conditionally activated T-cell bispecific to EGFR and CD3. The design includes single patient cohorts and a 3+3 design. Escalating dose increments will be determined in discussion with a Safety Review Committee.
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
- •Histologically confirmed metastatic or locally advanced unresectable solid tumor. Must have received prior standard therapy.
- •Measurable disease per RECIST 1.1
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •Adequate baseline laboratory values
- •Patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control from signing the ICF, and for a period of 30 days after the last dose of CX-
- •Additional inclusion criteria may apply
排除标准
- •History of malignancy that was active within the previous 2 years. Exceptions include localized cancers that are not related to the current cancer being treated, that are considered to have been cured, and in the opinion of the Investigator, present a low risk of recurrence
- •Screening electrocardiogram demonstrating a mean QTcF value > 480 msec; a screening echocardiogram with left ventricular ejection fraction (LVEF) < 50%
- •Serious concurrent illness
- •History of or current active autoimmune diseases
- •History of myocarditis regardless of the cause
- •Pregnant or breast feeding
- •Additional exclusion criteria may apply
研究组 & 干预措施
CX-904
干预措施: CX-904 (Drug)
结局指标
主要结局
Patients Experiencing Dose-limiting Toxicity
时间窗: 12 months
The number of patients experiencing a dose-limiting toxicity (DLT) as defined in the protocol at any dose level during dose escalation.
次要结局
- Objective Response Rate (ORR)(30 months)
- Duration of Response (DOR)(30 months)
- Investigator-assessed Progression-Free Survival (PFS)(30 months)
- Disease Control Rate (DCR)(30 months)
- Overall Survival (OS)(30 months)