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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, With or Without BI 754091, in Patients With Stage IV Colorectal Cancer

Trial Profile

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, With or Without BI 754091, in Patients With Stage IV Colorectal Cancer

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 15 Nov 2019

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At a glance

  • Drugs ATP 128 (Primary) ; BI 754091 (Primary)
  • Indications Colorectal cancer
  • Focus Adverse reactions; First in man; Proof of concept
  • Acronyms KISIMA-01
  • Sponsors Amal Therapeutics
  • Most Recent Events

    • 02 Aug 2019 Status changed from planning to recruiting.
    • 02 May 2019 According to an Amal Therapeutics media release, this trial is expected to begin in the second half of 2019.
    • 26 Mar 2019 According to a Natera media release, the company will partner with AMAL Therapeutics for this trial.This study adds to the growing number of pharmaceutical trials using Nateras Signatera molecular residual disease (MRD) assay as a biomarker to assess treatment response.
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