EUCTR2019-004699-21-IT进行中（未招募）1 期
A Phase 2/3 Trial to Evaluate Margetuximab in Combination with INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients with Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive Gastric or Gastroesophageal Junction Cancer - na
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 860
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 confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma
- •- Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS > or = 1%), per central review
- •- Cohort B: HER2-positive (by IHC 3+ or IHC 2+ in combination with FISH+) by local review. PD -L1 status is not required for enrollment.
- •2. Availability of formalin-fixed, paraffin-embedded tumor specimen, unstained slides or contemporaneous biopsy for tumor target testing
- •3. Eastern Cooperative Oncology Group performance status of 0 or 1, verified within 3 days of Day 1
- •4. Life expectancy > or = 6 months
- •5. At least one radiographically measurable target lesion
- •6. Acceptable laboratory parameters and adequate organ function
- •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 460
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1. Other malignancy that is progressing or required treatment within the past 5 years, with certain exceptions
- •-Patients with known MSI-H status
- •2. History of allogeneic stem cell or tissue/solid organ transplant
- •3. Central nervous system metastases
- •4. Clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise
- •5. Prior neoadjuvant or adjuvant treatment with immunotherapy
研究者
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