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Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

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Trial Profile

Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 02 Apr 2024

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At a glance

  • Drugs Vebreltinib (Primary) ; Osimertinib
  • Indications Glioblastoma; Non-small cell lung cancer; Solid tumours
  • Focus Registrational; Therapeutic Use
  • Acronyms SPARTA
  • Sponsors Apollomics

    • Most Recent Events

    • 28 Mar 2024 According to an Apollomics media release, the Company will continue enrollment in the SPARTA cohort to increase the precision around the point estimate for ORR and provide geographic diversity for the purpose of accelerated approval of an NDA to potentially support a marketing authorization. The company expect enrollment of these incremental patients in SPARTA will continue into 2025.
    • 28 Mar 2024 According to an Apollomics media release, if results from SPARTA and KUNPENG studies are positive, the Company could potentially submit an NDA in 2026 to seek accelerated approval.
    • 28 Mar 2024 According to an Apollomics media release, in Feb 2024, the Company had a productive meeting with the FDA on clinical data requirements for a potential NDA during which interim results from the SPARTA and KUNPENG studies were included and based on the meeting, the Company will continue to enroll in SPARTA cohorts and will review additional information on patients from both the trials with the FDA .
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