A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07177950
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-A1811 — DRUG
    Systemic therapy: 4.8 mg/kg administered as an intravenous infusion on Day 1 of each cycle. 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.
  • SHR-A1811 — DRUG
    Intrathecal therapy: Administered intrathecally on Day 1 of each cycle. Dose escalation follows a Bayesian Optimal Interval (BOIN) design with three predefined dose levels-15 mg, 30 mg, and 40 mg. The starting dose level is 15 mg. Patients are enrolled in cohorts of three per dose level. If no dose-limiting toxicities (DLTs) are observed, escalation proceeds to the next higher dose level according to the BOIN algorithm. Treatment is administered for a minimum of two cycles and is continued until cerebrospinal fluid (CSF) cytology achieves negative conversion, completion of six cycles, or intolerable adverse events, whichever occurs first. Extension beyond six cycles may be permitted following investigator's discussion and must be documented with justification.
  • radiotherapy — RADIATION
    radiotherapy is determined by investigator's choice

Study Details

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.

Key Dates

First listed
Sep 17, 2025
Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
51 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Systemic SHR-A1811 therapy combined with intrathecal SHR-A1811 therapy
  • Experimental: Arm 2
    Systemic SHR-A1811 therapy combined with radiotherapy

Primary Outcome Measure

1. Number of Dose-Limiting Toxicities (DLTs) in the Sequential Dose-Escalation Cohort [ Time Frame: Start of treatment until 3-week follow-up ]

Central Contacts

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