NCT07458113

Sac-TMT for Active TNBC Brain Metastases

Sacituzumab Tirumotecan to Treat Patients With Brain Metastases From Triple-negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a multi-site prospective single-arm open-label phase 2 clinical trial including 20 participants with metastatic TNBC and active brain metastases to be treated with sacituzumab tirumotecan 4 mg/kg IV on Days 1, and 15 of every 28-day cycle until disease progression, unacceptable toxicities, consent withdrawal, or death.

Conditions

• Metastatic Triple Negative Breast Cancers

Interventions

Type	Name	Description
DRUG	Sacituzumab tirumotecan	Sacituzumab tirumotecan should begin within three days of registration. For all study interventions administered based on weight, the participant's weight at screening or at cycle 1, day 1 should be used to calculate the initial dose. The participant's weight will be determined before each dose of sacituzumab tirumotecan. If, at any time throughout the course of treatment, the participant's weight changes by ≥10% from baseline, the dose will be recalculated using this new weight and will be considered the new baseline for all subsequent dosing calculations. The dose(s) of study intervention(s) should be recalculated as needed throughout the study. Dose adjustments for changes in body weight \<10% are permitted per institutional standards. Sacituzumab tirumotecan will be administered by IV infusion on days 1, and 15 of each 28-day cycle. The duration of the sacituzumab tirumotecan infusions should be 90 minutes (±15 minutes), and infusion-related AEs will be monitored.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-05-01
• Completion: 2029-05-01
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study