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A Phase 1b/II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combined With IN10018 in Subjects With Locally Advanced or Metastatic Solid Tumors With KRAS G12C Mutation

Trial Profile

A Phase 1b/II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combined With IN10018 in Subjects With Locally Advanced or Metastatic Solid Tumors With KRAS G12C Mutation

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 26 Nov 2024

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At a glance

  • Drugs Garsorasib (Primary) ; Ifebemtinib (Primary)
  • Indications Colorectal cancer; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors InxMed
  • Most Recent Events

    • 21 Nov 2024 According to an InxMed media release, China National Medical Products Administration (NMPA) has granted Ifebemtinib (IN10018) Breakthrough Therapy designation (BTD) for the first-line (1L) treatment of non-small cell lung cancer (NSCLC) supported by data from this study.
    • 04 Jun 2024 Results (n=33; as of 31 Jan 2024) reporting preliminary data from phase II part of front-line NSCLCs with KRAS G12C mutation presented at the 60th Annual Meeting of the American Society of Clinical Oncology
    • 30 May 2024 According to an InxMed media release, as of May 10, 2024, a total of 33 subjects were enrolled in the study.

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