Trials / Active Not Recruiting
Active Not RecruitingNCT05445908
SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer
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 Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 175 (estimated)
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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 .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SKB264 | SKB264 will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle |
| DRUG | KL-A167 | KL-A167 will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle |
Timeline
- Start date
- 2022-08-17
- Primary completion
- 2027-09-01
- Completion
- 2027-09-01
- First posted
- 2022-07-06
- Last updated
- 2025-11-17
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05445908. Inclusion in this directory is not an endorsement.