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A Multicenter, Open Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-019 Monotherapy or Combination Anti-PD-1 Antibody in Patients With Advanced Malignant Tumors

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Trial Profile

A Multicenter, Open Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-019 Monotherapy or Combination Anti-PD-1 Antibody in Patients With Advanced Malignant Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 14 May 2025

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At a glance

  • Drugs LBL-019 (Primary) ; Antineoplastics
  • Indications Liver cancer; Malignant melanoma; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Nanjing Leads Biolabs

Most Recent Events

  • 07 May 2025 Planned primary completion date changed from 22 Mar 2025 to 22 Oct 2025.
  • 04 Jun 2024 Results (n=26; as of 2 Jan 2024) reporting preliminary safety and efficacy of LBL-019 in patients with advanced malignant tumors presented at the 60th Annual Meeting of the American Society of Clinical Oncology
  • 13 May 2024 According to a Leads Biolabs media release, the company will publish online data from this study at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting between May 31 to June 4, 2024 in Chicago.

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