HB1801 Combined Treatment of HER2-positive Breast Cancer

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study ID
NCT07116824
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • HB1801 — DRUG
    HB1801 is administered by intravenous infusion.
  • Trastuzumab — DRUG
    Trastuzumab is administered by intravenous infusion, 8mg/kg loading dose and then 6mg/kg per cycle, Q3W.
  • Pertuzumab — DRUG
    Pertuzumab is administered by intravenous infusion, 840mg loading dose and then 420mg per cycle, Q3W.
  • Docetaxel — DRUG
    Docetaxel is administered by intravenous infusion, 75mg/m\^2, Q3W.

Study Details

This study is designed to evaluate the safety and efficacy of HB1801 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic breast cancer.

Key Dates

First listed
Aug 12, 2025
Start date
Sep 15, 2025
Status verified
Aug 2025
Primary completion
Jul 15, 2026
Completion
Nov 7, 2027

Study Design

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

Arms

  • Experimental: Cohort 1：Combination of HB1801, Trastuzumab and Pertuzumab
    HB1801: per protocol; Trastuzumab: 8mg/kg loading dose and then 6mg/kg, Q3W; Pertuzumab: 840mg loading dose and then 420mg, Q3W
  • Active Comparator: Cohort 2：Combination of Docetaxel, Trastuzumab and Pertuzumab
    Docetaxel：75mg/m\^2 ，Q3W Trastuzumab: 8mg/kg loading dose and then 6mg/kg, Q3W; Pertuzumab: 840mg loading dose and then 420mg, Q3W

Primary Outcome Measure

Objective Response Rate (ORR) as assessed by RECIST 1.1 [ Time Frame: Up to approximately 2 years ]

Central Contacts

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