A Single center, Open-label, Non-comparative, Phase I/II clinical trial to Assess the Maximum Tolerated Dose (MTD), Safety and Efficacy of BEY1107 in Monotherapy and in Combination With Gemcitabine in Patient with Locally Advanced or Metastatic Pancreatic Cancer

BeyondBio Inc.0 个研究点目标入组 75 人开始时间: 待定最近更新: 2019年8月26日

适应症

试验速览

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•1)Subjects who have histopathologically or cytologically diagnosed with pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
•2)Subjects with one or more lesions that are measurable or evaluable with RECIST v1.1
•3)Subjects with an eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2
•4)Subjects with a life expectancy of at least 12 weeks as determined by an investigator
•5)Subjects with appropriate bone marrow, renal, and liver function at screening

•1) History of treatment of locally advanced or metastatic pancreatic cancer
•2) Where major surgery (e.g., surgery requiring general anesthesia, etc.) was performed, subjects for whom at least 4 weeks have not elapsed since the surgery as of the time of screening
•3) Subjects with an evidence for symptomatic uncontrolled brain metastasis (brain metastasis is permitted if it is radiologically and neurologically stable after stopping corticosteroid administration for at least 2 weeks prior)
•4) Subjects with an active bacterial infection who have been administered antibiotics within 7 days prior to screening (excluding local antibiotic treatment)
•5) Subjects with a history of malignant tumor other than basal cell carcinoma, cervix carcinoma in situ, and papillary thyroid cancer within 5 years prior to screening
•6) Pregnant women, breastfeeding women, and women of childbearing potential
•7) Subjects infected with HIV or active hepatitis B or C (provided that subjects in whom the virus is not detected may be enrolled)

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