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临床试验/EUCTR2017-002566-50-FR
EUCTR2017-002566-50-FR进行中（未招募）1 期

A Phase 2 Study of IMAB362 as Monotherapy or in Combination with mFOLFOX6 in Subjects with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma whose Tumors have High or Intermediate Claudin (CLDN) 18.2 Expression - ILUSTRO

Astellas Pharma Global Development, Inc. (APGD)0 个研究点目标入组 102 人开始时间: 2018年4月3日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
102
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

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
  • •2. Subject is considered an adult according to local regulation at the time of signing informed consent.
  • •3. Female subject must either:
  • •- Be of non-childbearing potential:
  • •Postmenopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to screening, or
  • •Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
  • •- Or, if of childbearing potential:
  • •Agree not to try to become pregnant during the study and for 6 months after the final study drug administration And have a negative serum pregnancy test at screening (Note: Subjects with elevated serum beta human chorionic gonadotropin (ßhCG) and a demonstrated non-pregnant status through additional testing are eligible.)
  • •And, if heterosexually active, agree to consistently use 1 form of highly effective birth control starting at screening and throughout the study period and for 6 months after the final study drug administration
  • •4. 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.
  • •5. Female subject must agree not to donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.
  • •6. A sexually active male subject with a female partner(s) who is of childbearing potential is eligible if:
  • •Agree to use a male condom starting at screening and continue throughout study treatment and for 6 months after the final study drug administration.
  • •If the male subject has not had a vasectomy or is not sterile as defined below their female partner(s) is utilizing 1 form of highly effective birth control starting at screening and continue throughout study treatment and for 6 months after the male subject receives their final study drug administration.
  • •7. 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.
  • •8. 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.
  • •9. Subject has histologically confirmed gastric or GEJ adenocarcinoma.
  • •10. Subject has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study treatment.
  • •11. Subject has measurable disease according to RECIST 1.1 within 28 days prior to the first dose of study treatment. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following
  • •radiation therapy.
  • •12. Subject’s tumor sample has CLDN18.2 expression (defined as moderate to strong membranous staining by central IHC testing) as follows:
  • •Cohorts 1A and 2: CLDN18.2 high expression (= 75% of tumor cells); Cohorts 1B: CLDN18.2 high or intermediate expression (= 50% of tumor cells)
  • •13. Cohorts 1A and 1B Only: Subject has disease progression on or after at least 2 prior regimens for their advanced disease, including fluoropyrimidine and platinum-containing chemotherap

排除标准

  • •1. Subject has had prior severe allergic reaction or intolerance to a monoclonal antibody, 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. 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) are allowed.
  • •5. Subject has gastric outlet syndrome or persistent recurrent vomiting.
  • •6. Subject with recent gastric bleeding or symptomatic subjects with proven gastric ulcers that would preclude the subject from participation per investigator judgment.
  • •7. Subject has known active central nervous system metastases and/or carcinomatous meningitis.
  • •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. Subjects who are negative for HBsAg, but hepatitis B core antibody positive, will have a hepatitis B DNA test performed and if positive will be excluded. Subjects with positive serology, but negative hepatitis C virus RNA test results, are eligible.
  • •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.
  • •11. Subject has active autoimmune disease that has required systemic treatment in the past 2 years.
  • •12. 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.
  • •13. Subject has psychiatric illness or social situations that would preclude study compliance per investigator’s judgment.
  • •14. Subject has had a major surgical procedure without complete recovery within 28 days before start of study treatment.
  • •15. Subject has had radiotherapy within 14 days (Cohort 1) and within 28 days (Cohort 2) prior to start of study treatment. Subject who received palliative radiotherapy to peripheral bone metastases within 14 days prior to start of study treatment and has recovered from all acute
  • •toxicities is allowed.
  • •16. Subject has another past or active malignancy, which is likely to require treatment per investigator’s clinical judgment.
  • •17. Cohort 2 Only, subject has:
  • •- Prior severe allergic reaction or intolerance to any component of mFOLFOX6 chemotherapeutics in this study
  • •- Known dihydropyrimidine dehydrogenase deficiency
  • •- Known peripheral neuropathy > Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the subject ineligible).
  • •- Sinusoidal obstruction syndrome, formerly known as veno-occlusive disease, if present, should be stable or improving per investigator’s judgment.

研究者

发起方
Astellas Pharma Global Development, Inc. (APGD)

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