Advanced Malignant Tumors
Conditions
Brief summary
Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined with or without chemotherapy in advanced malignant tumors
Interventions
DRUGAK104
IV infusion,Specified dose on specified days
DRUGAK117
IV infusion,Specified dose on specified days
DRUGCapecitabine tablets
Oral,Specified dose on specified days
DRUGOxaliplatin
IV infusion,Specified dose on specified days
DRUGCisplatin
IV infusion,Specified dose on specified days
DRUGPaclitaxel
IV infusion,Specified dose on specified days
DRUGIrinotecan
IV infusion,Specified dose on specified days
DRUGDocetaxel
IV infusion,Specified dose on specified days
DRUG5-FU
IV infusion,Specified dose on specified days
Sponsors
Akeso
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
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 an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3. Have a life expectancy of at least 3 months. 4. Phase Ib: Histologically or cytologically confirmed advanced solid tumor. 5. Phase II: Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamous cell carcinoma. 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 |
|---|---|
| Number of patients with Adverse Events (AEs) | Up to approximately 2 years |
| Objective Response Rate (ORR) | Up to approximately 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Maximum observed concentration (Cmax) of AK117 and AK104 | From first dose of study drug to last dose of of study drug | The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration. |
| Minimum observed concentration (Cmin) of AK117 and AK104 at steady state | From first dose of study drug to last dose of of study drug | The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration. |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | From first dose of study drug through 30 days after last dose of study drug | The immunogenicity of AK117 and AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs). |
Countries
China
Contacts
Primary ContactWeifeng Song, MD
Outcome results
None listed