A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors
NCT ID: NCT05229497
Last Updated: 2022-05-11
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
114 participants
INTERVENTIONAL
2022-05-04
2024-02-29
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 AK112 (20 mg/kg Q3W) + AK117 (30 mg/kg QW)
AK112
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Phase Ib#Dosage regimen 2#
Subjects receive AK112 (20 mg/kg Q3W) + AK117 (45 mg/kg QW)
AK112
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Phase II#Cohort 1#
Head and neck squamous cell carcinoma (HNSCC): AK112 (20 mg/kg Q3W)
AK112
IV infusion,Specified dose on specified days
Phase II#Cohort 2#
HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)
AK112
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Phase II#Cohort 3#
HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)+Carboplatin/cisplatin+5-fluorouracil
AK112
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Carboplatin
IV infusion,Specified dose on specified days
Cisplatin
IV infusion,Specified dose on specified days
5-Fluorouracil
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
Carboplatin
IV infusion,Specified dose on specified days
Cisplatin
IV infusion,Specified dose on specified days
5-Fluorouracil
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 selected advanced solid tumor.
5. Phase II:
Cohort 1 and 2 :
A. Has histologically confirmed recurrent or metastatic HNSCC who had failed only first-line platinum-containing therapy.
B. Has histologically confirmed recurrent or metastatic HNSCC with PD-L1 positive (CPS≥1) without prior systemic antitumor therapy.
Cohort 3: Has histologically confirmed recurrent or metastatic HNSCC without prior systemic antitumor therapy.
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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Xiaozhong Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AK117-201
Identifier Type: -
Identifier Source: org_study_id
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