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

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT06099821
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Digestive System Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KN046 — DRUG
    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 — DRUG
    Regorafenib is a multi-target tyrosine kinase inhibitors and is one of the standard third-line therapy in mCRC
  • Apatinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 25, 2023
Status verified
Oct 2023
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients resistant to PD1/PDL1 blockade
    Patients with microsatellite instability-high digestive system cancers resistant to PD-1/PD-L1 blockade

Primary Outcome Measure

Progression free survival [ Time Frame: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose ]

Central Contacts