Last updated: August 9, 2022
Sponsor: Akeso
Overall Status: Active - Recruiting
Phase
1/2
Condition
Neoplasms
Treatment
N/AClinical Study ID
NCT05235542
AK117-204
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 to 75 years old.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have a life expectancy of at least 3 months.
- Phase Ib: Histologically or cytologically confirmed advanced solid tumor.
- Phase II: Has histologically confirmed diagnosis of unresectable locallyadvanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamouscell carcinoma.
- Have at least one measurable lesion based on Response Evaluation Criteria in SolidTumors (RECIST) 1.1 assessed by investigator.
- Has adequate organ function.
Exclusion
Exclusion Criteria:
- 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, immunecheckpoint agonists, immune cell therapy and other treatments targeting the mechanismof tumor immunity.
- History of severe bleeding tendency or coagulation disorder.
Study Design
Total Participants: 130
Study Start date:
July 12, 2022
Estimated Completion Date:
March 31, 2024
Connect with a study center
Shanghai Renji Hospital
Shanghai,
ChinaActive - Recruiting
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