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HB1801 Combined Treatment of HER2-positive Breast Cancer

ConditionHER2-positive Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Cohort 1：Combination of HB1801, Trastuzumab and PertuzumabExperimental treatment 3 interventions
Group B: Cohort 2：Combination of Docetaxel, Trastuzumab and PertuzumabActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) as assessed by RECIST 1.1

Time frame
Up to approximately 2 years

Secondary outcomes

1

Disease Control Rate (DCR) as assessed by RECIST 1.1

Time frame
Up to approximately 2 years
2

Duration of Response (DoR) as assessed by RECIST 1.1

Time frame
Up to approximately 2 years
3

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

Time frame
Up to approximately 2 years
4

Overall Survival (OS)

Time frame
Up to approximately 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: