Lucentis Plus Tagolimumab in PD-L1+, HR+/HER2- Advanced Breast Cancer After CDK4/6 Inhibitors

NCT ID: NCT07258108

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-21
• Study Completion Date: 2026-12-26

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lucanisatuzumab plus Tagolimumab

Lucanisatuzumab (5 mg/kg, Q2W) in combination with tagolimumab (900 mg, Q2W) administered intraveno

Group Type: EXPERIMENTAL

Lucanisatuzumab plus tagolimumab

Intervention Type: DRUG

Each participant receives Lucanisatuzumab plus tagolimumab intravenously.

Interventions

Lucanisatuzumab plus tagolimumab

Each participant receives Lucanisatuzumab plus tagolimumab intravenously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 18-75 years old.

2. HR+/HER2- breast cancer (BC), meeting the following conditions:

1. HR+/HER2-; HER2-(IHC 0 or 1+); IHC 2+(FISH negative); HR+ (ER and/or PR IHC showed ≥1%);

2. 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

1. Received chemotherapy during the advanced stage;

2. 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

3. Received immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibodies) in the advanced stage;

4. Recurrence or metastasis within 12 months of the last chemotherapy in the early stage;

5. Subjects with central nervous system (CNS) metastases. For subjects with brain metastases who have previously received local therapy,

6. 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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xu fei

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fei Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, Chile

Countries

Chile

Central Contacts

Fei Xu, MD

Role: CONTACT

xufei@sysucc.org.cn

+86-13711277870

Kuikui Jiang, MD

Role: CONTACT

jiangkk@sysucc.org.cn

+86-15210589011

Facility Contacts

Fei Xu, MD

Role: primary

xufei@sysucc.org.cn

+86-13711277870

Kuikui Jiang, MD

Role: backup

jiangkk@sysucc.org.cn

+86-15210589011

Other Identifiers

SYSU-2025

Identifier Type: -

Identifier Source: org_study_id