EUCTR2020-005767-31-ES进行中（未招募）1 期
A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination with Modified FOLFIRINOX (mFFX) With or Without Budigalimab compared to mFFX in Subjects with Untreated Metastatic Pancreatic Adenocarcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 129
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease
- •2) Measurable disease per RECIST 1.1
- •3) ECOG 0 or 1 and life expectancy of > 3 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 97
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •1) Previous radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma
- •2) Clinically significant third-space fluid accumulation
- •3) History of inflammatory bowel disease, non-infectious pneumonitis, interstitial lung disease, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS)
- •4) Positive test results for HIV, or subjects with chronic or active hepatitis B or C
- •5) Clinically significant uncontrolled medical conditions
研究者
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