Lucentis in Combination With Tagolimumab for the Treatment of PD-L1-Positive, HR-Positive/HER2-Negative Advanced Breast Cancer Previously Treated With CDK4/6 Inhibitors, a Phase II Study
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Sun Yat-sen University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- progression-free survival rate (PFS)
Overview
Brief Summary
This is a Phase II single-arm study designed to evaluate the efficacy and safety of Lucanisatuzumab + Tagolisumab in 35 patients with PD-L1+ HR+/HER2- advanced breast cancer who failed prior CDK4/6 inhibitor therapy. 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.
Detailed Description
This study is a prospective, single-arm, multicenter Phase II trial designed to evaluate the efficacy and safety of Lucanisatuzumab in combination with Tagolisumab for the treatment of PD-L1-positive, HR+/HER2- advanced breast cancer patients who have failed prior CDK4/6 inhibitor therapy.
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 Lucanisatuzumab (5 mg/kg, Q2W) combined with Tagolisumab (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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-75 years old.
- •HR+/HER2- breast cancer (BC), meeting the following conditions:
- •HR+/HER2-; HER2-(IHC 0 or 1+); IHC 2+(FISH negative); HR+ (ER and/or PR IHC showed ≥1%);
- •Tumor stage: Locally advanced, recurrent, or metastatic HR+/HER2- breast cancer; 3) Disease progression during or within 12 months after completion of adjuvant endocrine therapy based on a CDK4/6 inhibitor, or disease progression on CDK4/6 inhibitor treatment for metastatic disease; 4) PD-L1 positive (CPS ≥ 1); 5) At least one measurable target lesion as assessed by the investigator per RECIST 1.1; subjects with bone lesions only
Exclusion Criteria
- •Received chemotherapy during the advanced stage;
- •Received any targeted therapy against topoisomerase I during the advanced stage, including antibody-drug conjugates (ADCs) (e.g., anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies), or any immune cell therapy targeting
- •Received immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibodies) in the advanced stage;
- •Recurrence or metastasis within 12 months of the last chemotherapy in the early stage;
- •Subjects with central nervous system (CNS) metastases. For subjects with brain metastases who have previously received local therapy,
- •Other malignancies within 5 years prior to dosing (excluding locally treated and cured tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ);
Arms & Interventions
Lucanisatuzumab plus Tagolimumab
Lucanisatuzumab (5 mg/kg, Q2W) in combination with tagolimumab (900 mg, Q2W) administered intraveno
Intervention: Lucanisatuzumab plus tagolimumab (Drug)
Outcomes
Primary Outcomes
progression-free survival rate (PFS)
Time Frame: 6 months
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.
Secondary Outcomes
- Overall survival (OS)(1 year)
- Objective Response Rate (ORR)(1 year)
- Progression-Free Survival (PFS)(1 year)
- Disease Control Rate (DCR)(1 year)
- Duration of Response (DoR)(1 year)
Investigators
Xu fei
Associate Chief Physician
Sun Yat-sen University