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

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Trial Profile

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

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

Latest Information Update: 08 Oct 2024

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At a glance

  • Drugs Sotorasib (Primary) ; Midazolam; Programmed cell death-1 ligand-1 modulators
  • Indications Adenocarcinoma; Appendiceal cancer; Biliary cancer; Brain metastases; Bronchial cancer; Cholangiocarcinoma; Colorectal cancer; Endometrial cancer; Gastrointestinal cancer; Large cell carcinoma; Malignant melanoma; Non-small cell lung cancer; Oesophageal cancer; Pancreatic cancer; Small cell lung cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms CodeBreak100; CodeBreakTM 100
  • Sponsors Amgen

    • Most Recent Events

    • 04 Oct 2024 Planned End Date changed from 30 Apr 2028 to 30 May 2028.
    • 04 Oct 2024 Planned primary completion date changed from 16 Oct 2027 to 30 May 2028.
    • 22 Jul 2024 Planned End Date changed from 8 Nov 2027 to 30 Apr 2028.

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