At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating KN046, Regorafenib, and 1 other intervention for Digestive System Cancers. Currently recruiting, targeting 39 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.
Regorafenib is a multi-target tyrosine kinase inhibitors and is one of the standard third-line therapy in mCRC
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.