NCT07139470

Sacituzumab Tirumotecan Plus Anlotinib for Metastatic Triple Negative Breast Cancer

An Open-label, Single-arm, Multicenter Phase I/II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Anlotinib in Previously Treated Metastatic Triple Negative Breast Cancer (mTNBC).

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, multicenter phase I/II study to evaluate the safety and efficacy of sac-TMT plus anlotinib in previously treated mTNBC. The study is expected to enroll up to 59 eligible patients.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Tirumotecan + anlotinib	Phase I part: 3 prespecified doses (sac-TMT 4mg/kg Q2W +anlotinib 8mg Q3W, sac-TMT 4mg/kg Q2W +anlotinib10mg Q3W, sac-TMT 4mg/kg Q2W +anlotinib12 mg Q3W). Phase II part: sac-TMT patients Q2W +anlotinib RP2D Q3W.

Timeline

• Start date: 2025-08-15
• Primary completion: 2027-04-15
• Completion: 2027-10-15
• First posted: 2025-08-24
• Last updated: 2025-08-24

Locations

1 site across 1 country: China