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NCT Number: NCT07824869

A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients

This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously treated with HER2 ADC. Eligible participants will be treated with the study drug until the loss of clinical benefit, intolerable toxicity, initiation of new anti-tumor therapy, voluntary withdrawal from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).

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Key information

Conditions

HER2 + Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Experimental group: HLX22 + trastuzumab + investigator's choice of chemotherapy, once every 3 weeks (Q3W).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 18 years (or the legal age of adulthood per country-specific regulation) at the time of signing the ICF, male or female.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or - Life expectancy of ≥ 6 months.
  • Histologically confirmed breast cancer with radiologically or otherwise documented locally advanced unresectable and/or metastatic disease.
  • HER2 positive confirmed by central laboratory.
  • Hormone receptor (HR) status confirmed by local laboratory.
  • Patients who have progressed after treatment containing within HER2 ADC
  • Presence of at least one measurable lesion according to the RECIST v1.1.
  • Adequate organ function

Exclusion criteria

  • History of any other malignancy within 2 years prior to signing the ICF.
  • Prior use of doxorubicin with a cumulative in vivo dose of > 360 mg/m2.
  • Adverse events from prior anti-tumor treatment that have not resolved to Grade ≤ 1 or baseline level according to CTCAE v6.0.
  • Uncontrolled or severe cardiovascular disease.
  • History of cerebrovascular accident within 6 months prior to randomization.
  • Current (non-infectious) interstitial lung disease (ILD)/pneumonia that requires steroid treatment.
  • Active infection.
  • Active tuberculosis.
  • Presence of spinal cord compression or clinically symptomatic central nervous system metastases.
  • Receipt of systemic anti-tumor treatment and immunotherapy, within 4 weeks prior to randomization
  • Pregnant or lactating women or women who plan to become pregnant during the study period.
  • History of immunodeficiency or history of organ transplantation.

Treatment and study plan

HLX22

Drug

15 mg/kg, intravenous infusion (IV) on Day 1 (D1) of Q3W

Trastuzumab

Drug

Loading dose 8 mg/kg, maintenance dose 6 mg/kg, IV, Q3W, D1.

Capecitabine

Drug

1000 mg/m2, oral (po), twice daily (BID), D1-14, Q3W

paclitaxel

Drug

175 mg/m2, D1; or 80-90 mg/m2, D1 D8 D15, Q3W, IV

docetaxel

Drug

75-100 mg/m2, D1, Q3W, IV

Eribulin

Drug

1.4 mg/m2, D1 and D8, Q3W, IV

Vinorelbine

Drug

25-30 mg/m2, D1 and D8, Q3W, IV

Primary outcomes

  1. Objective response rate (ORR) assessed by the blinded independent central review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Time frame: Up to 2 years

    ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1

Secondary outcomes

  1. Progression-free survival (PFS) assessed by the BICR as per RECIST 1.1

    Time frame: up to 5 years

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.

  2. ORR assessed by the investigator as per RECIST 1.1

    Time frame: up to 2 years

  3. PFS assessed by the investigator as per RECIST 1.1

    Time frame: up to 5 years

  4. Duration of response (DoR) assessed by the BICR and the investigator as per RECIST 1.1

    Time frame: up to 2 years

    DoR is defined as the time from the date of first achievement of CR or PR (whichever is documented first) to the date of the first documentation of PD or death (whichever occurs first)

  5. Overall survival (OS)

    Time frame: up to 5 years

    OS is defined as the time from randomization to death due to any cause.

  6. Adverse Events (AEs)

    Time frame: time from the date of the first dose of study drug until 90 days after last dose, assessed up to 5 years

    Incidence and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) v6.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Mingxia Xu

CONTACT

[email protected]

+86 18905266695

Sponsors and collaborators

Lead sponsor

Shanghai Henlius Biotech

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 in Combination With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy in Locally Advanced Unresectable and/or Metastatic HER2-Positive Breast Cancer Previously Treated With HER2 ADC

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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