A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metast… (NCT07177950) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases
51 participantsStarted 2025-09-30
Plain-language summary
This is a multi-center, open-label, two-cohort study. The purpose of this study is to evaluate the safety, tolerability and efficacy of SHR-A1811 in the treatment of HER2-positive breast cancer with brain and leptomeningeal metastases, and the efficacy and safety of SHR-A1811 in the treatment of HER2-positive breast cancer with brain but without leptomeningeal metastases.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Women aged 18-75 years (inclusive).
✓. Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification).
✓. Radiologically documented brain metastases, with or without baseline leptomeningeal disease:
✓. Anticipated life expectancy \>12 weeks.
✓. ECOG performance status 0-2.
✓. Adequate organ function as defined by the following laboratory criteria:
✓. Hepatic: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) (≤5 × ULN in patients with liver metastases); total serum bilirubin (TBIL) ≤1.5 × ULN; serum albumin ≥30 g/L.
Exclusion criteria
✕. Cohort A participants must be excluded if any of the following apply:
✕. Cerebrospinal fluid (CSF) circulation obstruction that cannot be adequately controlled by therapeutic measures.
✕. MRI evidence of nodular leptomeningeal (LM) disease in the setting of negative CSF cytology.
✕. Active central nervous system (CNS) infection.
What they're measuring
1
1. Number of Dose-Limiting Toxicities (DLTs) in the Sequential Dose-Escalation Cohort
Timeframe: Start of treatment until 3-week follow-up
2
CNS-PFS
Timeframe: Start of treatment until 2-year follow-up
Trial details
NCT IDNCT07177950
SponsorPeking University Cancer Hospital & Institute
✕. Cohort B participants must be excluded if leptomeningeal metastasis is documented, defined as either: radiographic evidence of leptomeningeal involvement, or positive CSF cytology, or unequivocal clinical signs or symptoms attributable to leptomeningeal disease.
✕. Presence of clinically significant third-space fluid accumulation (e.g., massive pleural or peritoneal effusion) that cannot be adequately controlled by drainage or other interventions.
✕. Known hypersensitivity to any study drug or its excipients, or to any prior humanized monoclonal antibody products (e.g., trastuzumab, pertuzumab).