HB1801 Combined Treatment of HER2-positive Breast Cancer

NCT07116824 | Not Yet Recruiting Phase 2

• 1 other identifier: HB1801-014
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) as assessed by RECIST 1.1

  Up to approximately 2 years

Secondary Outcomes (5)

• Disease Control Rate (DCR) as assessed by RECIST 1.1

  Up to approximately 2 years

• Duration of Response (DoR) as assessed by RECIST 1.1

  Up to approximately 2 years

• Progression-free survival (PFS) as assessed by RECIST 1.1

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 2 years

• Incidence and severity of treatment-emergent adverse events (TEAE)

  Up to approximately 2 years

Study Arms (2)

Cohort 1：Combination of HB1801, Trastuzumab and Pertuzumab

EXPERIMENTAL

HB1801: per protocol; Trastuzumab: 8mg/kg loading dose and then 6mg/kg, Q3W; Pertuzumab: 840mg loading dose and then 420mg, Q3W

Drug: HB1801; Drug: Trastuzumab; Drug: Pertuzumab

Cohort 2：Combination of Docetaxel, Trastuzumab and Pertuzumab

ACTIVE COMPARATOR

Docetaxel：75mg/m\^2 ，Q3W Trastuzumab: 8mg/kg loading dose and then 6mg/kg, Q3W; Pertuzumab: 840mg loading dose and then 420mg, Q3W

Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel

Interventions

HB1801 DRUG

HB1801 is administered by intravenous infusion.

Cohort 1：Combination of HB1801, Trastuzumab and Pertuzumab

Trastuzumab DRUG

Trastuzumab is administered by intravenous infusion, 8mg/kg loading dose and then 6mg/kg per cycle, Q3W.

Cohort 1：Combination of HB1801, Trastuzumab and Pertuzumab; Cohort 2：Combination of Docetaxel, Trastuzumab and Pertuzumab

Pertuzumab DRUG

Pertuzumab is administered by intravenous infusion, 840mg loading dose and then 420mg per cycle, Q3W.

Cohort 1：Combination of HB1801, Trastuzumab and Pertuzumab; Cohort 2：Combination of Docetaxel, Trastuzumab and Pertuzumab

Docetaxel DRUG

Docetaxel is administered by intravenous infusion, 75mg/m\^2, Q3W.

Cohort 2：Combination of Docetaxel, Trastuzumab and Pertuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this study and sign the Informed Consent Form (ICF);
• Age ≥ 18 years;
• Histologically and/or cytologically confirmed unresectable locally recurrent or metastatic breast cancer;
• HER2-positive (IHC 3+, or IHC 2+ with ISH-positive);
• No prior systemic chemotherapy and/or HER2-targeted therapy for unresectable locally recurrent or metastatic breast cancer (participants who have received ≤1 line of endocrine therapy are eligible); Participants who relapsed \>12 months after completing (neo)adjuvant chemotherapy or HER2-targeted therapy may be considered for enrollment;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• At least one measurable lesion per RECIST 1.1. The measurable lesion should not have received local treatment such as radiotherapy (lesions in previously irradiated areas may be selected as target lesions if progression is confirmed). Target lesions cannot be bone-only metastases;
• Adequate organ and bone marrow function (without transfusion or hematopoietic growth factor support within 14 days prior to testing):
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L;
• Platelet count ≥ 100 × 10\^9/L;
• Hemoglobin ≥ 90 g/L;
• Liver function: Total bilirubin (TBIL) ≤ 1.0 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (ALT/AST≤ 5 × ULN for participants with liver metastases; AST/ALT ≤ 1.5 × ULN for participants with alkaline phosphatase (ALP) \> 2.5 × ULN);
• Renal function: Creatinine clearance ≥60 mL/min (calculated by Cockcroft-Gault formula);
• Coagulation: International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for participants receiving anticoagulation therapy, the investigator should confirm that INR and APTT are within safe and effective therapeutic ranges);
• Left ventricular ejection fraction (LVEF) \> 50%;

You may not qualify if:

• Contraindications to trastuzumab, pertuzumab, or docetaxel, or deemed by the investigator as unsuitable for treatment with HB1801, docetaxel, pertuzumab, or trastuzumab;
• Participants with ≥ Grade 3 peripheral neuropathy at randomization;
• Toxicities from prior anticancer therapy have not resolved to ≤ Grade 1 per CTCAE v5.0 (except for alopecia, peripheral neuropathy, or laboratory abnormalities deemed non-risky by the investigator, which must be ≤ Grade 2);
• History of LVEF decline to \< 50%, symptomatic congestive heart failure (CHF), or toxicity leading to permanent discontinuation during prior HER2-targeted therapy;
• Known hypersensitivity or contraindications to corticosteroids (including but not limited to active peptic ulcer, severe hypertension, severe hypokalemia, glaucoma, etc.);
• Prior anthracycline therapy exceeding cumulative doses of: Doxorubicin or liposomal doxorubicin \> 360 mg/m², Epirubicin \> 720 mg/m², Mitoxantrone \> 120 mg/m², Other anthracyclines \> doxorubicin-equivalent 360 mg/m²(If multiple anthracyclines were used, the total dose must not exceed 360 mg/m² doxorubicin-equivalent);
• Use of strong CYP3A4 inhibitors within 14 days before randomization;
• History of hypersensitivity to any study drug component or excipients;
• Untreated or unstable brain/spinal metastases, leptomeningeal disease, or cord compression (participants with treated, asymptomatic CNS lesions stable for ≥4 weeks on imaging, without edema, and off corticosteroids may be eligible);
• Active malignancies within 3 years prior to randomization, except: studied breast cancer, locally cured tumors (e.g., resected basal/squamous skin cancer, superficial bladder cancer, cervical/breast carcinoma in situ, early-stage thyroid cancer);
• Uncontrolled or significant cardiovascular disease, including:
• NYHA Class II+ CHF, unstable angina, myocardial infarction, or hemodynamically unstable arrhythmia within 6 months;
• Primary cardiomyopathy (e.g., dilated, hypertrophic, arrhythmogenic right ventricular, restrictive);
• Clinically significant QTc prolongation (Fridericia-corrected QTcF \> 450 ms at screening);
• Arterial/venous thromboembolism within 6 months (e.g., stroke, TIA, DVT, PE);

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Interventions

Trastuzumab; pertuzumab; Docetaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label, multi-center, randomized, Phase II clinical study.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 12, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): November 7, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08