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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib | Experimental | Subjects receive AK112 plus AK117 until progression |
|
| Phase II | Experimental | AK112 + chemotherapy± AK117 until progression; AK117 + chemotherapy; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK112 | Drug | IV infusion,Specified dose on specified days |
| |
| 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 |
| 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) |
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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.
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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jieer Ying, MD | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42409321 | Derived | Xu Q, Zhou S, Zhang C, Zhou Y, He Y, Jiang Y, Li J, Yi T, Luo C, Zhang L, Wu J, Zhang Y, Wu M, Wei Q, Li Q, Liu B, Chen X, Yao Y, Yu C, Li J, Ren Y, Zhuo W, Yuan L, Li W, Wang ZM, Li B, Xia M, Xie Y, Wu K, Ying J. Ivonescimab plus gemcitabine and cisplatin as first-line therapy for advanced biliary tract cancer: a multicenter, open-label phase 2 trial. J Hepatol. 2026 Jul 6:S0168-8278(26)02682-6. doi: 10.1016/j.jhep.2026.06.033. Online ahead of print. |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| AK117 |
| Drug |
IV infusion,Specified dose on specified days |
|
| Chemotherapy | Drug | IV infusion,Specified dose on specified days |
|
| Up to approximately 2 years |
| Progression free survival (PFS) | Up to approximately 2 years |
| Overall survival (OS) | Up to approximately 2 years |