A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors

Launched by AKESO · Jan 28, 2022

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 to 75 years old.
• • 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:
• • 1. Undergone major surgery within 30 days prior to the first dose of study treatment.
• • 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.