drugset / Trial / NCT05445908
SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KL-A167 | Unknown | — | Intravenous |
| Subject | Sacituzumab Tirumotecan | Other / unclassified | — | Intravenous |