A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy and in combination with Chemotherapy and/or Immunotherapy in Subjects with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma Whose are Claudin (CLDN) 18.2 Positive

Astellas Pharma Global Development, Inc.0 个研究点目标入组 143 人开始时间: 2020年8月20日最近更新: 2024年5月27日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方: Astellas Pharma Global Development, Inc.
入组人数: 143

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: >= 18age old 至 ot applicable（—）
性别: All

入选标准

•1. Female subject eligible to participate if she is not pregnant and at least one of the following conditions applies:
•a. Not a woman of child-bearing potential (WOCBP) OR
•b. WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study drugs.
•2. Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.
•3. Female subject must agree not to donate ova starting at screening and throughout the study period, and for 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study drugs.
•4. A sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
•5. Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.
•6. 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 period and for 6 months after the final study drug administration.
•7. Subject has histologically confirmed gastric or GEJ adenocarcinoma.
•8. Cohorts 1-4: Subject has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study treatment.
•9. Subjects tumor is positive for CLDN18.2 expression demonstrating moderate to strong membranous staining as determined by central IHC testing.
•10. Subject agrees to not participate in another interventional study while on treatment.
•11. Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
•12. Subject has predicted life expectancy >= 12 weeks.
•13. Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to the first dose of study treatment. In case of multiple central laboratory data within this period, the most recent data should be used.
•- Hemoglobin (Hgb) >= 9 g/dL (transfusion is allowed, but post-transfusion Hgb [24 hours or later following transfusion] must be >= 9 g/dL)
•Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
•Platelets >= 100 x 10^9/L
•Albumin >= 2.5 g/dL
•Total bilirubin <= 1.5 x upper limit of normal (ULN)
•Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x upper limit of normal (ULN) in subjects without liver metastases ( <= 5 x ULN if liver metastases are present)
•Cohorts 1-4: Estimated creatinine clearance >= 30 mL/min
•Cohort 5: Serum creatinine <=1.5 x ULN, or estimated creatinine clearance >= 50 mL/min for subjects with serum creatinine levels > 1.5 x ULN
•Prothrombin time/international normalized ratio and partial thromboplastin time <= 1.5 x ULN (except for subjects receiving anticoagulation therapy)
•Specific to Cohort 1A:
•1. Subject has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study treatment per investigator assessment. For subjects with only 1 evaluable lesion and prior radiotherapy <= 3 months before enrollment, the lesion mu

排除标准

•1. Subject has had prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.
•2. Subject has known immediate or delayed hypersensitivity or contraindication to any component of study treatment.
•3. Subject has received other investigational agents or devices concurrently or within 28 days prior to first dose of study treatment.
•4. Subject has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to first dose of study treatment.
•5. Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.
•6. Subject has significant gastric bleeding and/or untreated gastric ulcers that would preclude the subject from participation.
•7. Subject has history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.
•8. 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 [HBsAg]) or hepatitis C infection.
•9. Subject has had within 6 months prior to first dose of study treatment any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.
•10. Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study treatment.
•11. Subject has active autoimmune disease that has required systemic treatment within the past 3 months prior to the start of study treatment.
•12. Subject has a clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the subject unsuitable for study participation.
•13. Subject has psychiatric illness or social situations that would preclude study compliance.
•14. Subject has had a major surgical procedure <= 28 days before start of study treatment.
•15. Subject is without complete recovery from a major surgical procedure <= 14 days before start of study treatment
•16. Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma <= 14 days (Cohorts 1 and 3A) and <= 28 days (Cohorts 2 and 4A or 4B) prior to start of study treatment and has NOT recovered from any related toxicity.
•17. Subject has another malignancy, for which treatment is required.
•18. Cohort 2, 4, and 5 Only, subject has any of the following:
•o Prior severe allergic reaction or intolerance to any component of mFOLFOX6 or FLOT chemotherapeutics in this study
•o Known dihydropyrimidine dehydrogenase deficiency (DPD).
•o Known peripheral neuropathy > Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the subject ineligible).
•o Sinusoidal obstruction syndrome, formerly known as veno-occlusive disease, if present, should be stable or improving.
•o History of clinically significant ventricular arrhythmias.
•o QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects.
•o History or family history of congenital long QT syndrome.
•o Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for > 1 month prior to first dose of study treatment are eligible).
•19. Cohorts 3A, 4A and 4B Only, subject has any of the following:
•o Ongoing or previous autoimmune diseas

研究者

发起方

Astellas Pharma Global Development, Inc.

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