A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 99
- 试验地点
- 26
- 主要终点
- The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy
研究概览
简要总结
The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001
PROBODY is a trademark of CytomX Therapeutics, Inc
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 diagnosis of metastatic or locally advanced unresectable tumors
- •Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
- •Agreement to provide mandatory archival tissue or fresh biopsy.
- •At least 18 years of age.
排除标准
- •Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
- •Serious concurrent illness, including clinically relevant active infection
- •History of or current active autoimmune diseases
- •Significant cardiac disease such as recent myocardial infarction
- •History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
- •Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
- •History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
- •Currently receiving anticoagulation therapy with warfarin;
- •Major surgery (requiring general anesthesia) within 3 months prior to dosing.
研究组 & 干预措施
CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination
Additional enrollment into previously cleared monotherapy dose levels
干预措施: CX-2009 (Drug)
CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation
Dose escalation and determination
干预措施: CX-2009 (Drug)
CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion
Dose expansion
干预措施: CX-2009 (Drug)
CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion
Dose escalation and determination in selected tumor types
干预措施: CX-2009 (Drug)
结局指标
主要结局
The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy
时间窗: 21 days for the Q3W schedule, 28 days for the Q2W schedule
All AEs will be captured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 and considered for assessment of DLTs as outlined by the criteria in Protocol Table 5.
次要结局
- Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy(Median total on-study follow-up of 18.4 weeks.)