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An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer

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An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 03 Feb 2025

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At a glance

  • Drugs ATP 128 (Primary) ; Ezabenlimab (Primary)
  • Indications Colorectal cancer; Liver metastases
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Acronyms KISIMA-01
  • Sponsors Amal Therapeutics

    • Most Recent Events

    • 29 Jan 2025 Planned End Date changed from 31 Dec 2024 to 31 Aug 2025.
    • 29 Jan 2025 Planned primary completion date changed from 31 Jul 2024 to 31 May 2025.
    • 11 Sep 2024 Results assessing ATP128-specific immune response in the peripheral circulation of vaccinated patients presented at the CRI-ENCI: 8th Annual International Cancer, Immunotherapy Conference

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