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A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors

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Trial Profile

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 15 Jul 2026

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At a glance

  • Drugs Opamtistomig (Primary)
  • Indications Biliary cancer; Neuroendocrine carcinoma; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Sponsors Nanjing Leads Biolabs

Most Recent Events

  • 10 Jul 2026 According to Nanjing Leads Biolabs Co., Ltd. media release, company has announced that the biologics license application (BLA) for Opamtistomig as monotherapy for the treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China for inclusion in the priority review and approval procedure.
  • 04 Jun 2024 Results (as of october 31, 2023, n=162) assessing safety and efficacy presented at the 60th Annual Meeting of the American Society of Clinical Oncology
  • 17 May 2024 Planned number of patients changed from 370 to 396.

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