Advanced Malignant Tumors
Conditions
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（Anti-CD47 Antibody）with or without chemotherapy in advanced malignant tumors
Interventions
DRUGAK112
IV infusion,Specified dose on specified days
DRUGAK117
IV infusion,Specified dose on specified days
DRUGChemotherapy
IV infusion,Specified dose on specified days
Sponsors
Akeso
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 advanced solid tumor. 5. Phase II: cohort 1 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma. cohort 2 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic Biliary Tract Cancers, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer. cohort 3 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic pancreatic ductal adenocarcinoma. cohort 4 : Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer \[AJCC\] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;Have previously received EGFR-TKI treatment and have progressed on or following. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Adverse Events (AEs) | Up to approximately 2 years | Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs |
| Objective Response Rate (ORR) | Up to approximately 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) | Up to approximately 2 years |
| Duration of Response (DOR) | Up to approximately 2 years |
| Time to response (TTR) | Up to approximately 2 years |
| Progression free survival (PFS) | Up to approximately 2 years |
| Overall survival (OS) | Up to approximately 2 years |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJieer Ying, MD
Zhejiang Cancer Hospital
Outcome results
None listed