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Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors

NCT07258108 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-05-08

No results posted yet for this study

Summary

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

Interventions

DRUG

Lucanisatuzumab plus tagolimumab

Each participant receives Lucanisatuzumab plus tagolimumab intravenously.

Sponsors & Collaborators

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Fei Xu, MD · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-13
Primary Completion
2027-07-30
Completion
2028-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07258108 on ClinicalTrials.gov