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KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Aug 15, 2023 to Oct 26, 2023v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT05985109
Lead Sponsor Peking University Cancer Hospital & Institute
Conditions
(from sponsor)
Colorectal Cancer
Related terms Colorectal Neoplasms
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov