Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07560475
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Breast Cancer
  • HER2 + Breast Cancer
  • HER2positive

Eligibility Criteria

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

Interventions

  • SHR-A1811 — DRUG
    SHR-A1811 administered weekly
  • SHR-A1811 — DRUG
    SHR-A1811 administered every two weeks (q2w)
  • SHR-A1811 — DRUG
    SHR-A1811 administered every three weeks (q3w)

Study Details

An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer

Key Dates

First listed
May 1, 2026
Start date
Jun 10, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Weekly administration group
  • Experimental: Arm 2: Every-two-weeks (Q2W) administration group
  • Experimental: Arm 3: Every-three-weeks (Q3W) administration group

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From enrollment until disease progression or up to 2 years ]

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