Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases (TARGET-TNBC)

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Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: H. Lee Moffitt Cancer Center and Research Institute (other)

Phase: 1/2

Start date: Dec. 19, 2024

Planned enrollment: 31

Trial ID: NCT06238921
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: Zimberelimab (WBP-3055, GLS-010, AB122)

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Goal: Assess the safety and efficacy of stereotactic radiosurgery (SRS) followed by sacituzumab govitecan and zimberelimab for metastatic triple-negative breast cancer with brain metastases.

Patients: Adults with biopsy-confirmed triple-negative breast cancer, measurable brain metastases eligible for SRS, ECOG performance status 0–2, and prior taxane- and anthracycline-based chemotherapy. Patients with leptomeningeal disease are excluded.

Design: Phase I/II interventional study with one experimental arm listed and no randomization specified. Although the stated objective mentions comparison with sacituzumab govitecan alone, no comparator arm is described.

Treatments: SRS is followed one week later by sacituzumab govitecan 10 mg/kg on days 1 and 8 and zimberelimab 360 mg intravenously on day 1 of each 3-week cycle. Sacituzumab govitecan is a TROP-2-directed antibody–drug conjugate that delivers the topoisomerase I inhibitor SN-38. Zimberelimab is an investigational PD-1 antibody that blocks PD-1 signaling to support antitumor T-cell activity. In single-arm studies outside breast cancer, zimberelimab produced objective response rates of approximately 91% in relapsed or refractory classical Hodgkin lymphoma and 28% in recurrent or metastatic cervical cancer; these results do not establish efficacy in this trial population.

Outcomes: The phase I primary endpoint is grade 3 or higher neurologic toxicity during the first 9 weeks, including symptomatic radionecrosis, headache, memory impairment, and new-onset seizures. The phase II primary endpoint is progression-free survival through 12 months. Secondary endpoints include intracranial and extracranial progression-free survival, overall survival, and local and distant brain control.

Burden on patient: Moderate to high: participants undergo SRS, intravenous treatment on two days of each 3-week cycle, and response imaging every 9 weeks, requiring repeated visits and brain surveillance. No mandatory research biopsies or intensive pharmacokinetic blood draws are specified.

Last updated: Sep 2026

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Moffitt Cancer Center

Tampa, Florida, 33612, United States

[email protected] / 813-745-6911

Status: Recruiting

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