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

Sponsor
Sun Yat-sen University
Study ID
NCT07258108
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Lucanisatuzumab plus tagolimumab — DRUG
    Each participant receives Lucanisatuzumab plus tagolimumab intravenously.

Study Details

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.

Key Dates

Start date
Nov 13, 2025
Status verified
Nov 2025
Primary completion
Jul 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab Tirumotecan(Sac-TMT) plus Tagitanlimab(KL-A167)
    Sac-TMT (5 mg/kg, Q2W) in combination with KL-A167 (900 mg, Q2W) administered intraveno

Primary Outcome Measure

6-month progression-free survival rate (PFS) [ Time Frame: 6 months ]

Central Contacts

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