A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors
NCT ID: NCT05235542
Last Updated: 2022-08-11
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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UNKNOWN
PHASE1/PHASE2
130 participants
INTERVENTIONAL
2022-07-12
2024-03-31
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
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase Ib#Dosage regimen 1#
Subjects receive AK104 plus AK117 every 3- week cycle (Q3W) until progression
AK104
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Phase Ib#Dosage regimen 2#
Subjects receive AK104 plus AK117 every 6- week cycle (Q6W) until progression
AK104
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Phase II#Cohort 1#
Gastric Cancer or Gastroesophageal Junction Cancer: AK104 + XELOX (Oxaliplatin + Capecitabine)+AK117 every 3- week cycle (Q3W) until progression
AK104
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Capecitabine tablets
Oral,Specified dose on specified days
Oxaliplatin
IV infusion,Specified dose on specified days
Phase II#Cohort 2#
Esophageal squamous cell cancer: AK104 + 5-FU/Paclitaxel+Cisplatin± AK117 every 3- week cycle (Q3W) until progression
AK104
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Cisplatin
IV infusion,Specified dose on specified days
Paclitaxel
IV infusion,Specified dose on specified days
5-FU
IV infusion,Specified dose on specified days
Phase II#Cohort 3#
Gastric Cancer or Gastroesophageal Junction Cancer or Esophageal squamous cell cancer: AK117 +Paclitaxel/Docetaxel/Irinotecan every 3- or 4- week cycle (Q3W or Q4W) until progression
AK117
IV infusion,Specified dose on specified days
Paclitaxel
IV infusion,Specified dose on specified days
Irinotecan
IV infusion,Specified dose on specified days
Docetaxel
IV infusion,Specified dose on specified days
Interventions
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AK104
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Capecitabine tablets
Oral,Specified dose on specified days
Oxaliplatin
IV infusion,Specified dose on specified days
Cisplatin
IV infusion,Specified dose on specified days
Paclitaxel
IV infusion,Specified dose on specified days
Irinotecan
IV infusion,Specified dose on specified days
Docetaxel
IV infusion,Specified dose on specified days
5-FU
IV infusion,Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Have a life expectancy of at least 3 months.
4. Phase Ib: Histologically or cytologically confirmed advanced solid tumor.
5. Phase II: Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamous cell carcinoma.
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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Liwei Wang, MD
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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Shanghai Renji Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Liwei Wang
Role: primary
Other Identifiers
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AK117-204
Identifier Type: -
Identifier Source: org_study_id
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