EUCTR2017-002567-17-IT进行中（未招募）1 期
A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 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. - SPOTLIGHT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 550
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.Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] Authorization for US sites) must be obtained from the subject or legally authorized representative (if applicable) prior to any studyrelated procedures.
- •2.Subject is considered an adult (e.g., = 18 years of age in the US) according to local regulation at the time of signing the informed consent.
- •3.Subject agrees not to participate in another interventional study while on study treatment.
- •4.A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at Screening; female subjects with elevated serum beta human chorionic gonadotropin (ßhCG) and a
- •demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies:
- •a.Not a woman of childbearing potential (WOCBP) as defined in Appendix 12.3 Contraception Requirements
- •b.WOCBP who agrees to follow the contraceptive guidance as defined in Appendix 12.3 Contraception Requirements throughout the treatment period and for at least 6 months after the final study drug
- •administration.
- •5.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.
- •6.Female subject must not donate ova starting at Screening and throughout the study period, and for 6 months after the final study drug administration.
- •7.A sexually active male subject with female partner(s) who are of childbearing potential must agree to use contraception as detailed in Appendix 12.3 Contraception Requirements during the treatment period
- •and for at least 6 months after the final study drug administration.
- •8.Male subject must not donate sperm starting at Screening and throughout the study period and for 6 months after the final study drug administration.
- •9.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 for the time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.
- •Disease Specific Criteria:
- •10.Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
- •11.Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.
- •12.Subject has radiologically evaluable disease (measurable and/or nonmeasurable disease according to 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.
- •13.Subject's tumor expresses CLDN18.2 in = 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing.
- •14.Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.
- •Physical or Laboratory Findings
- •15.Subject has ECOG performance status 0 to 1.
- •16.Subject has predicted life expectancy ~12 weeks in the opinion of the investigator.
- •17.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 c
排除标准
- •Prohibited Treatment or Therapies
- •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 as long as it was completed at least 6 months prior to randomization. Subject may have received treatment with herbal medications that have known antitumor activity > 28 days prior
- •randomization.
- •2.Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma = 14 days prior to randomization and recovered from any related toxicity.
- •3.Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. 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 premedication for radiologic imaging contrast use are allowed.
- •4.Subject has received other investigational agents or devices within 28 days prior to randomization.
- •Medical History or Concurrent Disease
- •5.Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.
- •6.Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
- •7. Subject has prior severe allergic reaction or intolerance to any component of mFOLFOX6.
- •8.Subject has known dihydropyrimidine dehydrogenase deficiency (DPD). (NOTE: Screening for DPD deficiency should be conducted per local requirements.)
- •9.Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
- •10.Per investigator judgment, subject has significant gastric bleeding and/or untreated gastric ulcers that exclude the subject from participation.
- •11.Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive HBs Ag) or C infection. NOTE: Screening for these infections
- •should be conducted per local requirements.
- •a.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.
- •b.Subjects with positive hepatitis C (HCV) serology, but negative HCV RNA test are eligible.
- •c.Subjects treated with HCV with undetectable viral load results are eligible.
- •12.Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization.
- •13.Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.
- •14.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 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 Pointesc. QTc interval > 450 msec for male subjects: QTc interval > 470 msec for female subjects
- •d.History or family history of congenital
研究者
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