Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients (NCT07560475) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients
China60 participantsStarted 2026-06-30
Plain-language summary
An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged ≥ 18 years old.
✓. Pathologically confirmed HER2-positive advanced breast cancer. HER2 positivity is defined as IHC 3+ in \>10% immunoreactive cells or HER2 gene amplification confirmed by in situ hybridization (ISH), which shall be verified by the pathology department of the participating center.
✓. Patients with advanced breast cancer who have received no more than 2 lines of prior systemic therapies.
✓. Expected survival time ≥ 4 months.
✓. Have at least one measurable lesion per RECIST 1.1 criteria (helical CT scan lesion diameter ≥ 10 mm with slice thickness ≤ 5 mm).
✓. Adequate major organ function without blood transfusion.
✓. Voluntarily participate in the study, sign informed consent form, with good compliance and willingness to complete follow-up visits.
Exclusion criteria
✕. Prior treatment with anti-HER2 antibody-drug conjugates (ADC).
✕. Known leptomeningeal metastasis or active brain metastasis.
✕. A history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma. Malignancies cured solely by surgery more than 5 years prior to enrollment are allowed.
✕. Major surgery or severe trauma within 4 weeks before enrollment, or planned major surgery during the study period.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From enrollment until disease progression or up to 2 years
Trial details
NCT IDNCT07560475
SponsorTianjin Medical University Cancer Institute and Hospital
✕. Participation in other investigational new drug clinical trials within 4 weeks prior to enrollment.
✕. Presence of hereditary bleeding tendency or coagulation disorders.
✕. Uncontrolled hypertension with systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg despite standard antihypertensive therapy.
✕. A history of clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, active pneumonia, pulmonary fibrosis and radiation pneumonitis (excluding asymptomatic post-radiation changes without treatment requirement).