Actively Recruiting
Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors
Led by Sun Yat-sen University · Updated on 2026-05-08
35
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
F
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase II single-arm study designed to evaluate the efficacy and safety of Sac-TMT + KL-A167 in 35 patients with PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor. The primary endpoint is the 6-month PFS rate. Treatment will continue until disease progression or intolerable toxicity, with periodic imaging assessments and survival follow-up.
CONDITIONS
Official Title
Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Hormone receptor-positive (ER and/or PR ≥1%), HER2-negative breast cancer
- Locally advanced, recurrent, or metastatic HR+/HER2- breast cancer
- Disease progression during or within 12 months after adjuvant endocrine therapy with CDK4/6 inhibitor, or progression on CDK4/6 inhibitor for metastatic disease
- PD-L1 positive with combined positive score (CPS) ≥1
- At least one measurable target lesion per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy greater than 12 weeks
- Adequate organ function including specified blood counts, liver, kidney, coagulation, and heart function
- Effective contraceptive measures for participants of reproductive potential from consent until 6 months after last dose
- Voluntary participation with signed informed consent and willingness to comply with study requirements
You will not qualify if you...
- Received chemotherapy, targeted therapy against topoisomerase I including ADCs, immune checkpoint agonists, or immune cell therapy during advanced stage
- Recurrence or metastasis within 12 months of last chemotherapy in early stage
- Central nervous system (CNS) metastases, including brain metastases without prior local therapy
- Other malignancies within 5 years prior to dosing except treated and cured basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
F
Fei Xu, MD
CONTACT
K
Kuikui Jiang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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