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.
This study is a prospective, single-arm, multicenter Phase II study designed to evaluate the efficacy and safety of Sac-TMT in combination with KL-A167 for the treatment of PD-L1-positive, HR+/HER2- metastatic breast cancer patients who previously treated with CDK4/6. The study plans to enroll 35 patients. The primary endpoint is the 6-month progression-free survival (PFS) rate assessed by the investigator (RECIST v1.1). Secondary endpoints include PFS, objective response rate (ORR), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety. An exploratory endpoint is to analyze the correlation between TROP2 and PD-L1 expression and efficacy. The treatment regimen consists of intravenous administration of Sac-TMT (5 mg/kg, Q2W) combined with KL-A167 (900 mg, Q2W). Treatment will continue until disease progression or occurrence of intolerable toxicity. Tumor assessments will be conducted every 6 weeks for the first 6 months, followed by every 12 weeks thereafter. Safety follow-up will occur after treatment completion, with telephone follow-ups every 3 months to collect survival and subsequent treatment information.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Each participant receives Lucanisatuzumab plus tagolimumab intravenously.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITING6-month progression-free survival rate (PFS)
The proportion of subjects who remained free of radiographic disease progression or death within 6 months of receiving the first dose of study treatment, relative to the total number of subjects.
Time frame: 6 months
Objective Response Rate (ORR)
The proportion of subjects achieving complete response (CR) or partial response (PR) relative to the total number of subjects
Time frame: 1 year
Progression-Free Survival (PFS)
The time from the first administration of study treatment to the first occurrence of radiographic disease progression or death, whichever occurs first
Time frame: 1 year
Disease Control Rate (DCR)
The proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) relative to the total number of subjects
Time frame: 1 year
Duration of Response (DoR)
The time interval from the first documented disease response to disease progression or death (whichever occurs first)
Time frame: 1 year
Overall survival (OS)
The time from the first administration of the study treatment to the participant's death from any cause
Time frame: 1 year
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