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A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreakTM 100)

Trial Profile

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreakTM 100)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Dec 2019

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At a glance

  • Drugs AMG 510 (Primary)
  • Indications Appendiceal cancer; Colorectal cancer; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms CodeBreakTM 100
  • Sponsors Amgen
  • Most Recent Events

    • 27 Nov 2019 Study arm changed form 4 to 5 to include treatment naive advanced NSCLC patients, number of planned patients changed from 328 to 350. Trial focus changed from AR to TU and AR.
    • 27 Nov 2019 Planned End Date changed from 31 Mar 2023 to 6 Apr 2023.
    • 27 Nov 2019 Planned primary completion date changed from 29 Dec 2022 to 6 Apr 2023.
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