Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
250 participants
INTERVENTIONAL
2022-01-22
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase Ib
Subjects receive AK112 plus AK117 until progression
AK112
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Phase II
AK112 + chemotherapy± AK117 until progression; AK117 + chemotherapy;
AK112
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Chemotherapy
IV infusion,Specified dose on specified days
Interventions
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AK112
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Chemotherapy
IV infusion,Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
2. Have a life expectancy of at least 3 months.
3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Phase Ib:Histologically or cytologically confirmed advanced solid tumor.
5. Phase II:
cohort 1 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma.
cohort 2 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic Biliary Tract Cancers, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer.
cohort 3 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic pancreatic ductal adenocarcinoma.
cohort 4 : Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer \[AJCC\] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;Have previously received EGFR-TKI treatment and have progressed on or following.
6. Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
7. Has adequate organ function.
Exclusion Criteria
2. Active central nervous system (CNS) metastases.
3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
4. Active Hepatitis B or Hepatitis C.
5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
6. History of severe bleeding tendency or coagulation disorder.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Principal Investigators
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Jieer Ying, MD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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AK117-202
Identifier Type: -
Identifier Source: org_study_id
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