Clinical Trial

SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer

Active, Not Recruiting Phase 2
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Summary
The purpose of this study is to assess the safety and tolerability and preliminary antitumor activity of SKB264 with/without KL-A167 in patients with unresectable locally advanced, recurrent or metastatic TNBC and HR+/HER2- BC .The study is divided into three parts.Part 1（TNBC）: exploratory phase of the efficacy and safety of the combination treatment. Part 2（TNBC）: The subjects will be randomized to treatment group for SKB264 + KL-A167 or SKB264 . Part 3（HR+/HER2- BC）: The subjects will be randomized to treatment group for SKB264 + KL-A167 or SKB264 .
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-06-30; most recent amendment 2026-05-05.
Status change: Recruiting → Active, Not Recruiting 2025-11-13
Status change: Not Yet Recruiting → Recruiting 2023-10-17
Trial Details
NCT Number NCT05445908
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Triple-negative Breast Cancer and HR+/HER2- BC
Enrollment 175 participants
Start Date 2022-08-17
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-08