JPRN-jRCT2031210644招募中1 期
A Phase 1/1b Study of ASP2138 in Participants with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression
Guseva Maria0 个研究点目标入组 240 人开始时间: 2022年3月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
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
- •General Criteria
- •1.Participant is considered an adult according to local regulation at the time of signing the informed consent form (ICF).
- •2.Female participant is not pregnant, confirmed by serum pregnancy test and medical evaluation by interview and at least 1 of the following conditions apply:
- •a.Not a woman of childbearing potential (WOCBP)
- •b.WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final study intervention administration.
- •3.Female participant must agree not to breastfeed starting at screening and throughout the study period and for 6 months after the final study intervention administration.
- •4.Female participant must not donate ova starting at screening and throughout the study period and for 6 months after the final study intervention administration.
- •5.Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 6 months after the final study intervention administration.
- •6.Male participant must not donate sperm during the treatment period and for 6 months after the final study intervention administration.
- •7.Male participant with 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 intervention administration.
- •8.Participant's tumor sample is positive for claudin (CLDN)18.2 expression by central immunohistochemistry (IHC) testing.
- •9.Participant has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study intervention .
- •10.Participant has at least 1 measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study intervention. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •11.Participant has QT interval by Fredericia (QTcF) =< 470 msec.
- •12.Participant agrees not to participate in another interventional study while receiving study treatment in the present study.
- •13.Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •14.Participant has predicted life expectancy >= 12 weeks.
- •15.Participant must meet all criteria based on laboratory tests within 7 days prior to the first dose of study drug. In case of multiple laboratory data within this period, the most recent data should be used. If a participant has received a recent blood transfusion, the laboratory tests must be obtained >= 2 weeks after any blood transfusion.
- •Disease Specific Criteria: Gastric/GEJ Cancer
- •1.Participant has histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma.
- •2.Participant with gastric or GEJ adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).
- •Disease Specific Criteria: Pancreatic Cancer
- •1.Participant has histologically or cytologically confirmed pancreatic adenocarcinoma.
- •2.Participant with pancreatic adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical (no limit to the number o
排除标准
- •1.Participant has received other investigational agents, or antineoplastic therapy including immunotherapy or devices concurrently or within 21 days or 5 times the half-life, whichever is shorter, prior to first dose of study intervention administration.
- •2.Participant has any condition, which makes the participant unsuitable for study participation.
- •3.Participant has known immediate or delayed hypersensitivity or contraindication to any component of study treatment.
- •4.Participant has had prior severe allergic reaction or intolerance to known ingredients of ASP2138 or other antibodies, including humanized or chimeric antibodies.
- •5.Participant weighs < 40 kg.
- •6.Participant has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to first dose of study intervention. Participant 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 daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast use are allowed.
- •7.Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
- •8.Participant has significant gastric bleeding and/or untreated gastric ulcers that exclude the participant from participation.
- •9.Participant has symptomatic central nervous system (CNS) metastases or participant has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for no longer than 2 weeks.
- •10.Participant is known to have HIV infection. However, participants with cluster of differentiation (CD4) + T cell counts >= 350 cells/microL and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months are eligible. NOTE: Screening for human immunodeficiency virus (HIV) infection should be conducted per local requirements.
- •11.Participant is known to have active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements. NOTE: Screening for these infections should be conducted per local requirements.
- •- For participant who is negative for HBsAg, but hepatitis B core antibody (HBc Ab) positive, a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test will be performed and if positive the participant will be excluded.
- •- Participant with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test results are eligible.
- •- Participant treated for HCV with undetectable viral load results are eligible
- •12.Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.
- •13.Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.
- •14.Participant has active autoimmune disea
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