Sacituzumab Tirumotecan Plus Anlotinib for Metastatic Triple Negative Breast Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07139470
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab Tirumotecan + anlotinib — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 24, 2025
Start date
Aug 15, 2025
Status verified
Aug 2025
Primary completion
Apr 15, 2027
Completion
Oct 15, 2027

Study Design

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

Arms

  • Experimental: sac-TMT+anlotinib
    In the Phase I part, BOIN design was used. There were 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). In the Phase II part, the patients will receive sac-TMT patients Q2W +anlotinib RP2D Q3W. The treatment will continue until disease progression, unacceptable toxic effects, withdrawal from the trial, or death, whichever occurred first.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: up to approximately 60 months ]

Central Contacts

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