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A Phase I, Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of DZD1516 in Combination With Trastuzumab and Capecitabine, or DZD1516 in Combination With T-DM1, in Patients With Metastatic HER2 Positive (HER2+) Breast Cancer

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Trial Profile

A Phase I, Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of DZD1516 in Combination With Trastuzumab and Capecitabine, or DZD1516 in Combination With T-DM1, in Patients With Metastatic HER2 Positive (HER2+) Breast Cancer

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Apr 2025

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At a glance

  • Drugs Capecitabine (Primary) ; DZD 1516 (Primary) ; Trastuzumab (Primary) ; Trastuzumab emtansine (Primary)
  • Indications Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Adverse reactions
  • Sponsors Dizal Pharmaceutical

Most Recent Events

  • 01 Apr 2025 Status changed from active, no longer recruiting to completed.
  • 10 Dec 2022 Results (As of June 23,2022) assessing the safety of efficacy of DZD1516 in patients with HER2 positive metastatic breast cancer, presented at the 45th Annual San Antonio Breast Cancer Symposium.
  • 13 Sep 2022 Results assessing (n=22; As of February 20, 2022) safety and pharmacokinetics of DZD1516 for the treatment of HER2-positive metastatic breast cancer, presented at the 47th European Society for Medical Oncology Congress.

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