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Patients with microsatellite instability-high digestive system cancers resistant to PD-1/PD-L1 blockade

KN046 is a recombinant humanized PD-L1/CTLA-4 bispecific single-domain antibody that blocks both PD-L1 interaction with PD-1 and CTLA-4 interaction with CD80/CD86.

KN046

Regorafenib is a multi-target tyrosine kinase inhibitors and is one of the standard third-line therapy in mCRC

Regorafenib

Apatinib is a novel, small molecule, selective vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor and is the second anti-angiogenic drug to be approved in China for the treatment of advanced or metastatic gastric cancer. It has been also reported to have anti-tumor efficacy in other kinds of digestive system cancers.

Zhenghang Wang

Ting Xu

Zhenghang Wang, Dr

Lin Shen

The study is an interventional phase II clinical trial aiming to evaluate the efficacy and safety of KN046, a PD-L1 and CTLA-4 bispecific antibody, in combination with regorafenib or apatinib for microsatellite instability-high digestive system cancers resistant to PD-1/PD-L1 blockade. KN046 plus regorafenib will be given for patients with colorectal cancers, and KN046 plus apatinib will be given for patients with gastric cancers (including esophageal-gastric junction cancers) and other kinds of digestive system cancers.

KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

A Phase II Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib or Apatinib for Microsatellite Instability-High Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

Progression-free survival (PFS) is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic progressive disease (PD) or death due to any cause.

Objective response rate (defined as CR+PR) will be reported based on investigator's evaluation.

Disease control rate (defined as CR+PR+SD) will be reported based on investigator's evaluation.

Duration of response (DOR) is defined as the time from the date of the first response to the first objective documentation of radiographic progressive disease (PD) or death due to any cause.

Overall survival (OS) is defined as the time from the date of first dose to the date of death from any cause.

A treatment-related adverse event (TRAE) is defined as any adverse event not present prior to the initiation of drug treatment or any adverse event already present that worsens in intensity or frequency following exposure to the drug treatment. TRAEs were graded using National Cancer Institute (NCI)-CTCAE version 5.0.

Spots Global Cancer Trial Database for digestive system cancers