drugset / Trial / NCT05445908

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

NCT05445908

Phase 2 Active not recruiting 175 enrolled Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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 .

Timeline

Start
2022-08-17
Primary completion
2027-09
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject KL-A167 Unknown Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified Intravenous

Indications