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: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 20 Nov 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

17 Nov 2025 Planned End Date changed from 1 Jul 2025 to 1 Sep 2027.
17 Nov 2025 Planned primary completion date changed from 1 Apr 2025 to 1 Sep 2027.
17 Nov 2025 Status changed from recruiting to active, no longer recruiting.

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