Actively Recruiting
Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
376
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.
CONDITIONS
Official Title
Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 6 18 to 4 75 years at the time of signing the informed consent form
- Histologically and/or cytologically confirmed HR+/HER2- breast cancer based on recent pathology reports
- Failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage
- At least one measurable lesion per RECIST 1.1; patients with only skin or bone lesions are excluded
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
- Expected survival of at least 12 weeks
- Adequate organ and bone marrow function
- Eligible for a chemotherapy regimen in the control group
- Female patients of childbearing potential and male patients with partners of childbearing potential agree to use effective contraception from consent until 6 months after last dose
- Voluntary participation with signed informed consent and ability to comply with study visits and procedures
You will not qualify if you...
- History or presence of central nervous system (CNS) metastases
- Other malignancies within 3 years prior to first dose, except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix
- Any cardio cerebral vascular disease or risk factors affecting treatment
- Uncontrollable systemic diseases as assessed by investigator
- History of interstitial lung disease (ILD) or noninfectious pneumonitis requiring steroids, current ILD/noninfectious pneumonitis, or findings at screening that cannot exclude ILD/noninfectious pneumonitis
- Serious lung injuries caused by lung diseases
- Active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal bleeding
- Toxicities from prior anti-tumor therapy not recovered to Grade 1 or less
- Active hepatitis B or hepatitis C infection
- Positive HIV antibody test, history of AIDS, or active syphilis infection
- Known allergy or hypersensitivity to SKB264 or its excipients
- Prior TROP2 targeted therapy or prior topoisomerase I inhibitor therapy including antibody-drug conjugate therapy
- Major surgeries within 4 weeks before first dose or planned major surgeries during the study
- Concomitant infections requiring systemic antibiotics within 2 weeks before first dose
- Receipt of live vaccines within 30 days before first dose or planned live vaccines during the study
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
Y
Yina Diao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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