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Sacituzumab Tirumotecan Plus Tagitanlimab in Previously Treated Locally Advanced or Metastatic Triple Negative Breast Cancer

NCT07153965 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-09-04

No results posted yet for this study

Summary

This is an open-label, single-arm, multicenter phase II study to evaluate the safety and efficacy of sac-TMT plus Tagitanlimab in patients with PD-L1-positive locally advanced or metastatic TNBC.

Conditions

  • Triple Negative Breast Cancer (TNBC)
  • PD-L1 Positive

Interventions

DRUG

Sacituzumab Tirumotecan plus Tagitanlimab

Sacituzumab Tirumotecan 5mg/kg intravenously (IV) infusion every 2 weeks on Day 1, Tagitanlimab 900mg IV every 2 weeks on Day 1, until disease progression, unacceptable toxic effects, withdrawal from the trial, or death, whichever occurred first.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-01
Completion
2027-09-01

Countries

  • China

Study Locations

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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 NCT07153965 on ClinicalTrials.gov