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FL 301

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Drug Profile

FL 301

Alternative Names: Anti-claudin18.2 mAb - Leap Therapeutics; CLDN18.2 eADCC; FL-301; NBL-015

Latest Information Update: 28 May 2025

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At a glance

  • Originator NovaRock Biotherapeutics
  • Developer Leap Therapeutics; NovaRock Biotherapeutics
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Gastric cancer; Pancreatic cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I Gastric cancer; Pancreatic cancer
  • No development reported Solid tumours

Most Recent Events

  • 28 May 2025 No recent reports of development identified for phase-I development in Solid-tumours(Late-stage disease, Metastatic disease) in China (IV, Infusion)
  • 13 Sep 2023 Phase-I clinical trials in Gastric cancer (Late-stage disease, Metastatic disease) in China (IV)
  • 13 Sep 2023 Phase-I clinical trials in Pancreatic cancer (Late-stage disease, Metastatic disease) in China (IV)

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