EUCTR2021-001967-26-ES进行中（未招募）1 期
Open-label study of tusamitamab ravtansine (SAR408701) in combination with ramucirumab in participants previously treated for advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma with CEACAM5-positive tumors - CARMEN-GC01
Sanofi aventis recherche & développement0 个研究点目标入组 38 人开始时间: 2021年7月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
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
- •Histologically or cytologically confirmed diagnosis of gastric or GEJ adenocarcinoma.
- •Metastatic disease or locally advanced, unresectable disease.
- •Participants who have measurable target lesion.
- •Participants with high carcinoembryonic antigen-related cell adhesion molecule (CEACAM5) expression as per central assessment on tumor biospsy
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- •Female participant who agrees to use effective contraceptive methods during and for at least 7 months after the last dose of treatment administration
- •Male participant who agrees to use effective contraception methods during and for at least 4 months after the last dose of treatment administration
- •Signed informed consent
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Untreated brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
- •Significant concomitant illness.
- •History within the last 3 years of an invasive malignancy other than that treated in this study
- •Known uncontrolled infection
- •Nonresolution of any prior treatment-related toxicity
- •Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy
- •Use of contact lenses
- •Radiographic evidence of major airway or blood vessel invasion or intratumor cavitation
- •History of uncontrolled hereditary or acquired thrombotic disorder or history of aneurism
- •Major surgery within 28 days prior to Day 1/first IMP infusion; subcutaneous venous access device placement within 7 days prior to Day 1; or postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months
- •History of gross hemoptysis (defined as bright red blood or =1/2 teaspoon) within 2 months before the first treatment administration
- •Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months before the first administration of treatment administration
- •Uncontrolled arterial hypertension (systolic =150 mmHg or diastolic =90 mmHg) despite standard medical management.
- •Serious or nonhealing wound, skin ulcer, or bone fracture within 28 days before the first administration of treatment administration
- •Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to first administration of treatment administration
- •Significant bleeding disorders, vasculitis, or Grade 3-4 gastrointestinal (GI) bleeding within 3 months before the first administration of study intervention.
- •Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea
- •Medical condition requiring concomitant administration of a medication with a narrow therapeutic window and metabolized by CYP450 or a strong CYP3A inhibitor
- •Concurrent treatment with any other anticancer therapy
- •Prior treatment targeting CEACAM5 or containing maytansinoid DM1 or DM4 or ramucirumab or taxane or targeting VEGF/VEGFR
- •Poor organ function
研究者
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