A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared with Placebo Plus CAPOX as First-line Treatment of Subjects with Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Astellas Pharma Global Development, Inc.0 个研究点目标入组 507 人开始时间: 2018年11月30日最近更新: 2023年11月20日

试验速览

阶段: 3 期
状态: 已完成
发起方: Astellas Pharma Global Development, Inc.
入组人数: 507

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 ot applicable（—）
性别: All

入选标准

•1. Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
•2. Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.
•3. Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to Response Evaluation Criteria In Solid Tumors [RECIST 1.1]), per local assessment, =< 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy =< 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.
•4. Subject's tumor expresses CLDN18.2 in >= 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.
•5. Subject has a HER2-negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.
•6. Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
•7. Subject has predicted life expectancy >= 12 weeks.
•8. Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.
•o Hemoglobin (Hb) >= 9 g/dl. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb >= 9 g/dL.
•o Absolute Neutrophil Count (ANC) >= 1.5x10^9/L
•o Platelets >= 100x10^9/L
•o Albumin >= 2.5 g/dL
•o Total Bilirubin =< 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)
•o Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN without liver metastases (or =< 5 x ULN if liver metastases are present)
•o Estimated creatinine clearance >= 30 mL/min
•o Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) =< 1.5 x ULN (except for subjects receiving anticoagulation therapy)
•9. A female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
•o Not a woman of childbearing potential (WOCBP) OR
•o WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.
•10. Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study treatment administration.
•11. Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.
•12. A male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for 6 months after the final study treatment administration.
•13. A male subject must not donate sperm during the treatment period and for 6 months after the final study treatment administration.
•14. Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study

排除标准

•1. Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to randomization.
•2. Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma =< 14 days prior to randomization and has not recovered from any related toxicity.
•3. Subject has received treatment with herbal medications or other treatments that have known antitumor activity within 28 days prior to randomization.
•4. Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization.
•5. Subject has received other investigational agents or devices within 28 days prior to randomization.
•6. Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.
•7. Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
•8. Subject has prior severe allergic reaction or intolerance to any component of CAPOX.
•9. Subject has known dihydropyrimidine dehydrogenase (DPD) deficiency.
•10. Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
•11. Subject has significant gastric bleeding and/or untreated gastric ulcers that exclude the subject from participation.
•12. Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection.
•13. Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization.
•14. Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.
•15. Subject has significant cardiovascular disease, including any of the following:
•a)Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization.
•b) History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes
•c) QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects
•d) History or family history of congenital long QT syndrome
•e) Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible).
•16. Subject has a history of central nervous system (CNS) metastases and/or carcinomatous meningitis from gastric/GEJ cancer.
•17. Subject has known peripheral sensory neuropathy > grade 1.
•18. Subject has had a major surgical procedure =< 28 days prior to randomization.
•Subject is without complete recovery from a major surgical procedure =< 14 days prior to randomization.
•19. Subject has psychiatric illness or social situations that would preclude study compliance.
•20. Subject has another malignancy for which treatment

研究者

发起方

Astellas Pharma Global Development, Inc.

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