CTIS2024-511649-21-00招募中1 期
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 Tumors are Claudin (CLDN) 18.2 Positive. - 8951-CL-0103
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 143
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable)., Cohorts 1-4: Subject has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study treatment., Subject's tumor sample has CLDN18.2 expression, demonstrating moderate to strong membranous staining as determined by central IHC testing., Subject agrees not to participate in another interventional study while on treatment., Subject has ECOG performance status 0 to 1., Subject has predicted life expectancy = 12 weeks in the opinion of the investigator., 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 posttransfusion Hgb [24 hours or later following transfusion] must be = 9 g/dL) - Absolute neutrophil count (ANC) = 1.5 × 109/L - Platelets = 100 × 109/L - Albumin = 2.5 g/dL - Total bilirubin = 1.5 × upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN in subjects without liver metastases (= 5 × ULN if liver metastases are present) - Cohorts 1-4: Estimated creatinine clearance = 30 mL/min - Cohort 5: Serum creatinine <1.5 × ULN, or estimated creatinine clearance > 50 mL/min for subjects with serum creatinine levels > 1.5 × ULN - Prothrombin time/international normalized ratio and partial thromboplastin time = 1.5 × ULN (except for subjects receiving anticoagulation therapy), Subject is considered an adult according to local regulation at the time of signing informed consent., Female subject is eligible to participate if she is not pregnant [See Appendix 12.6 Contraception Requirements] and at least one of the following conditions applies: a. Not a woman of child-bearing potential (WOCBP) as defined in Appendix 12.6 Contraception Requirements OR b. WOCBP who agrees to follow the contraceptive guidance as defined in Appendix 12.6 Contraception Requirements 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, 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., Female subject must agree not to donate ova starting at screening and throughout the study, and for 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study drugs., A sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception as detailed in Appendix 12.6 Contraception Requirements during the treatment period and for at least 6 months after the final study drug administration., 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., Male subject with a pregnant or breastfeeding partner(s) must a
排除标准
- •Subject has had prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies, Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study treatment., Subject has active autoimmune disease that has required systemic treatment within the past 3 months prior to the start of study treatment., Subject has a clinically significant disease or co-morbidity that in the opinion of the investigator may adversely affect the safe delivery of treatment within this study or make the subject unsuitable for study participation., Subject has psychiatric illness or social situations that would preclude study compliance per investigator's judgment., Subject has had a major surgical procedure less or equal to 28 days before start of study treatment., Subject is without complete recovery from a major surgical procedure less or equal to 14 days before start of study treatment., Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma less or equal to 14 days (Cohorts 1 and 3A) and less or equal to 28 days (Cohorts 2 and 4A or 4B) prior to start of study treatment and has NOT recovered from any related toxicity., Subject has another malignancy for which treatment is required, per investigator's clinical judgment., Subject has known immediate or delayed hypersensitivity or contraindication to any component of study treatment., Subject has received other investigational agents or devices concurrently or within 28 days prior to first dose of study treatment., Subject has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to first dose of study treatment. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast use are allowed., Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting., Per investigator judgment, subject has significant gastric bleeding and/or untreated gastric ulcers that would preclude the subject from participation per investigator judgment., Subject has history of active central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer., 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. NOTE: Screening for these infections should be conducted per local requirements. - For subjects who are negative for HBs Ag, but HBc Ab positive, an HB DNA test will be performed and if positive the subject will be excluded. - Subjects with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results are eligible. - Subjects treated for HCV with undetectable viral load results are eligible., 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.
研究者
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