A Study of AK112 in Advanced Malignant Tumors

Study Overview
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Brief Summary
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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

Official Title
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A Phase Ib/II Study of AK112（PD-1 / VEGF Bispecific Antibody） in Combination With AK117（Anti-CD47 Antibody）With or Without Chemotherapy in Advanced Malignant Tumors

Conditions
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Advanced Malignant Tumors

Intervention / Treatment
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* Drug: AK112
* Drug: AK117
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 advanced solid tumor. 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. 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 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, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity. History of severe bleeding tendency or coagulation disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase Ib<br>Subjects receive AK112 plus AK117 until progression | Drug: AK112<br>* IV infusion,Specified dose on specified days<br>Drug: AK117<br>* IV infusion,Specified dose on specified days<br>|
| Experimental: Phase II<br>AK112 + chemotherapy± AK117 until progression | Drug: AK112<br>* IV infusion,Specified dose on specified days<br>Drug: AK117<br>* IV infusion,Specified dose on specified days<br>Drug: Chemotherapy<br>* IV infusion,Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Adverse Events (AEs) | Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs | Up to approximately 2 years | 
| Objective Response Rate (ORR) |  | Up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |