NCT03706274撤回1 期
A Phase 1, Open-Label, Dose-Ranging Study of the PD-1 Probody Therapeutic CX-188 in Adults With Recurrent or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-188 as a monotherapy
研究概览
简要总结
The purpose of this first-in-human study of CX-188 is to characterize the safety, tolerability, pharmacokinetics (PK), and antitumor activity of CX-188 in adult subjects with metastatic or advanced unresectable solid tumors that progressed on standard therapy: PROCLAIM: PRObody Clinical Assessment in Man CX-188 clinical trial 001
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •histologically confirmed diagnosis of metastatic or advanced unresectable solid tumors that progressed on standard therapy
- •agreement to provide mandatory archival tumor or fresh biopsy before they can be considered for inclusion in the study
- •At least 18 years old
排除标准
- •Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
- •History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic
- •Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C
- •History of or current active autoimmune diseases
- •History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications
- •History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant
- •Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug
- •Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug
研究组 & 干预措施
CX-188 Escalation
Experimental
干预措施: CX-188 (Drug)
CX-188 Alternative Dosing Schedule
Experimental
干预措施: CX-188 (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-188 as a monotherapy
时间窗: 21 days
次要结局
- The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-188 as monotherapy(2 years)
研究者
研究点 (1)
Loading locations...
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