OncRef

Clinical Trial: NCT05445908

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

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Information Provided By:Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Last Update Posted:2026-08-28

Study Overview

Brief 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 .

Official Title

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

Conditions

Triple-negative Breast Cancer and HR+/HER2- BC

Intervention / Treatment

  • Drug: SKB264
  • Drug: KL-A167

Other Study ID Numbers

  • SKB264-Ⅱ-07

Start Date (Actual)

2022-08-17

Primary Completion Date (Actual)

2026-07-31

Study Completion Date (Actual)

2026-07-31

Enrollment (Actual)

184

Study Type

Interventional

Phase

Phase 2