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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: 28 Nov 2023

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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

    • 23 Oct 2023 Planned End Date changed from 9 May 2027 to 8 Nov 2027.
    • 23 Oct 2023 Planned primary completion date changed from 9 May 2027 to 8 Nov 2027.
    • 06 Jun 2023 Results of Matching-adjusted indirect treatment comparison assessing the efficacy and safety of sotorasib with standard of care trifluridine/tipiracil and regorafenib as monotherapy treatments using data from NCT01607957, NCT01103323 and NCT03600883 trials, presented at the 59th Annual Meeting of the American Society of Clinical Oncology.
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