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

NCT07824869 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: HLX22-BC202
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).

Conditions

HER2 + Breast Cancer

Outcome Measures

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

  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

  Up to 2 years

Secondary Outcomes (6)

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

  up to 5 years

• ORR assessed by the investigator as per RECIST 1.1

  up to 2 years

• PFS assessed by the investigator as per RECIST 1.1

  up to 5 years

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

  up to 2 years

• Overall survival (OS)

  up to 5 years

Study Arms (2)

Experimental group

EXPERIMENTAL

HLX22 + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine)

Drug: HLX22; Drug: Trastuzumab; Drug: Capecitabine; Drug: Paclitaxel; Drug: Docetaxel; Drug: Eribulin; Drug: Vinorelbine

Control group

PLACEBO COMPARATOR

placebo + trastuzumab + investigator's choice of chemotherapy (capecitabine or paclitaxel or docetaxel or eribulin or vinorelbine)

Drug: Trastuzumab; Drug: Capecitabine; Drug: Paclitaxel; Drug: Docetaxel; Drug: Eribulin; Drug: Vinorelbine

Interventions

HLX22 DRUG

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

Experimental group

Trastuzumab DRUG

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

Control group; Experimental group

Capecitabine DRUG

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

Control group; Experimental group

Paclitaxel DRUG

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

Control group; Experimental group

Docetaxel DRUG

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

Control group; Experimental group

Eribulin DRUG

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

Control group; Experimental group

Vinorelbine DRUG

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

Control group; Experimental group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Capecitabine; Paclitaxel; Docetaxel; eribulin; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Central Study Contacts

Mingxia Xu

CONTACT

+86 18905266695; Mingxia_Xu@henlius.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 4, 2029
• Last Updated: September 17, 2026

Record last verified: 2026-09