KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Subjects are able to comprehend the informed consent form, voluntarily participate, and sign the informed consent form. * Subjects are ≥18 years old on the day of signing the informed consent form, with no gender restrictions. * Histologically confirmed digestive system cancers. * According to RECIST 1.1 criteria, there should be at least one measurable or evaluable lesion at baseline. If the subject has only one measurable or evaluable lesion at baseline, the lesion must not have been exposed to radiotherapy previously, or there must be evidence of significant progression after radiotherapy treatment completion. * ECOG performance status of 0 or 1. * Expected survival ≥3 months. * Archived tumor tissue samples or freshly obtained tumor tissue samples are available. * Female subjects of childbearing potential or male subjects with partners of childbearing potential agree to use highly effective contraception from 7 days before the first dose until 120 days after t