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An Open-label, Multi-center Phase I/II Clinical Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Effectiveness of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

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Trial Profile

An Open-label, Multi-center Phase I/II Clinical Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Effectiveness of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 Nov 2023

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At a glance

  • Drugs GFH 925 (Primary)
  • Indications Adenocarcinoma; Brain metastases; Colorectal cancer; Gastrointestinal cancer; Non-small cell lung cancer; Pancreatic cancer; Solid tumours
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Sponsors Innovent Biologics
  • Most Recent Events

    • 24 Nov 2023 According to a GenFleet Therapeutics media release, results will be presented at the upcoming European Society for Medical Oncology (ESMO) Asia Congress 2023.
    • 24 Nov 2023 According to a GenFleet Therapeutics media release, the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for GFH925 (IBI351) and granted GFH925 with Priority Review designation, for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy, based on results from this trial.
    • 13 Aug 2023 Three new primary end-points are added including two efficacy end-points, thus making "TU" also a trial focus.
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