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Phase 1, Single-arm, Open-label, Dose Escalating and Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of Lurbinectedin (PM01183) for Injection in Patients With Advanced Solid Tumors

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Trial Profile

Phase 1, Single-arm, Open-label, Dose Escalating and Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of Lurbinectedin (PM01183) for Injection in Patients With Advanced Solid Tumors

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 09 Dec 2024

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At a glance

  • Drugs Lurbinectedin (Primary)
  • Indications Small cell lung cancer; Solid tumours
  • Focus Registrational; Therapeutic Use
  • Sponsors Luye Pharma Group

Most Recent Events

  • 03 Dec 2024 According to a PharmaMar media release, company has received conditional marketing approval for (lurbinectedin) from the China National Medical Products Administration (NMPA) for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression during or after platinum-based chemotherapy. This approval is based on the results of this study.
  • 06 Jun 2024 Status changed from recruiting to completed.
  • 04 Dec 2023 According to Luye Pharma Group media release, based on data from two clinical studies of Lurbinectedin conducted in China and overseas; Lurbinectedin for injection has been approved by the Pharmaceutical Administration Bureau in Macao for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression upon or after receiving platinum-based chemotherapy.

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