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A Phase Ib/II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of JMT103 in Surgically Unsalvageable or Refractory Giant Cell Tumor of Bone

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Trial Profile

A Phase Ib/II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of JMT103 in Surgically Unsalvageable or Refractory Giant Cell Tumor of Bone

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

Latest Information Update: 16 Oct 2023

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At a glance

  • Drugs Narlumosbart (Primary) ; Calcium; Vitamin D
  • Indications Bone cancer; Giant cell tumours
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Jinmante Biotechnology

Most Recent Events

  • 06 Sep 2023 According to a CSPC Pharmaceutical Group Limited media release, the National Medical Products Administration (NMPA) of the Peoples Republic of China approval is based on two pivotal clinical studies (JMT103CN03 Phase II Pivotal Clinical Study and JMT103CN03-1 Real-World Study) in the treatment of unresectable or surgically difficult giant cell tumor of bone.
  • 06 Sep 2023 According to a CSPC Pharmaceutical Group Limited media release, the biologic license application (BLA) for Narlumosbart for Injection (JMT103), developed by Shanghai JMT-Bio Technology Co., Ltd. for the treatment of giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity has been approved by the National Medical Products Administration (NMPA) of the Peoples Republic of China.
  • 13 Oct 2022 Planned End Date changed from 1 May 2022 to 1 Oct 2023.

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