Status:
UNKNOWN
A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors
Lead Sponsor:
Akeso
Conditions:
Advanced Malignant Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117#AntiCD47 Antibody# in advanced malignant tumors
Eligibility Criteria
Inclusion
- 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 selected advanced solid tumor.
- 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.
- Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
- Has adequate organ function.
Exclusion
- 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 the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
- Active Hepatitis B or Hepatitis C.
- Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
- History of severe bleeding tendency or coagulation disorder.
Key Trial Info
Start Date :
May 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05229497
Start Date
May 4 2022
End Date
February 1 2024
Last Update
May 11 2022
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000