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A Phase 2 Clinical Study of SKB264 With/Without KL-A167 in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-negative Breast Cancer Who Have Not Received Prior Systemic Therapy

Trial Profile

A Phase 2 Clinical Study of SKB264 With/Without KL-A167 in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-negative Breast Cancer Who Have Not Received Prior Systemic Therapy

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 30 Apr 2025

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At a glance

  • Drugs Sacituzumab Tirumotecan (Primary) ; Tagitanlimab (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer; Triple negative breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms OptiTROP-Breast05
  • Sponsors Sichuan Kelun-Biotech Biopharmaceutical

Most Recent Events

  • 24 Apr 2025 According to Kelun Pharmaceutical media release, data from this trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • 17 Oct 2023 Number of treatment arms have been increased from 3 to 5 by the addition of 2 more experimental arms.
  • 17 Oct 2023 Planned number of patients changed from 95 to 175.

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