Phase
Condition
Neoplasms
Treatment
AK112
Chemotherapy
AK117
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 to 75 years old.
Have a life expectancy of at least 3 months.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Phase Ib:Histologically or cytologically confirmed advanced solid tumor.
Phase II: cohort 1 : Has histologically confirmed diagnosis of unresectable locallyadvanced,recurrent or metastatic gastric or GEJ adenocarcinoma. cohort 2 : Has histologically confirmed diagnosis of unresectable locallyadvanced,recurrent or metastatic Biliary Tract Cancers, including intrahepaticcholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer. cohort 3 : Has histologically confirmed diagnosis of unresectable locallyadvanced,recurrent or metastatic pancreatic ductal adenocarcinoma. cohort 4 : Has a histologically or cytologically confirmed stage IIIB/IIIC (AmericanJoint Committee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fitfor radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamousNSCLC;Have previously received EGFR-TKI treatment and have progressed on orfollowing.
Have at least one measurable lesion based on Response Evaluation Criteria in SolidTumors (RECIST) 1.1 assessed by investigator.
Has adequate organ function.
Exclusion
Exclusion Criteria:
Undergone major surgery within 30 days prior to the first dose of study treatment.
Active central nervous system (CNS) metastases.
History of active autoimmune disease that has required systemic treatment in thepast 2 years (i.e.,corticosteroids or immunosuppressive drugs).
Active Hepatitis B or Hepatitis C.
Received previous immunotherapy, including immune checkpoint inhibitors, immunecheckpoint agonists, immune cell therapy and other treatments targeting themechanism of tumor immunity.
History of severe bleeding tendency or coagulation disorder.
Study Design
Connect with a study center
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310000
ChinaSite Not Available
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