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Sacituzumab Tirumotecan Plus Anlotinib for Metastatic Triple Negative Breast Cancer

NCT07139470 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-08-24

No results posted yet for this study

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

Interventions

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.

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
2025-08-15
Primary Completion
2027-04-15
Completion
2027-10-15

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 NCT07139470 on ClinicalTrials.gov