KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer

The study is an interventional Phase II clinical trial aiming to optimize immunotherapy strategies for microsatellite-stable colorectal cancer. We will include three types of metastatic colorectal cancer patients: those without liver metastasis, or carrying BRAF V600E mutation, or unable to tolerate chemotherapy as their initial or second-line treatment. The participants will receive a combination treatment of regorafenib and KN046 which is a PD-L1/CTLA-4 bispecific antibody. Treatment efficacy and safety profile would be evaluated in this study.

Trial Details

NCT ID
NCT05985109
Phase
PHASE2
Sponsor
Peking University Cancer Hospital & Institute
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • KN046
  • regorafenib
Locations (sample)
  • Beijing, China|39.9075,116.39723

Key Eligibility Criteria

  • I01. Subjects are able to comprehend the informed consent form, voluntarily participate, and sign the informed consent form.
  • I02. Subjects are ≥18 years old on the day of signing the informed consent form, with no gender restrictions.
  • I03. Histologically confirmed colorectal adenocarcinoma, including signet ring cell carcinoma and mucinous adenocarcinoma.
  • I04. According to RECIST 1.1 criteria, there should be at least one measurable or evaluable lesion at baseline. If the subject has only one measura…

For full eligibility, visit ClinicalTrials.gov.

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