New biosimilar aims to match phesgo for breast cancer treatment

NCT ID NCT07601620

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
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The treatment has been approved, so it is available normally rather than through this programme.

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new biosimilar drug, HLX319, works as well as the approved drug Phesgo for people with HER2-positive early or locally advanced breast cancer. About 258 participants will receive either the biosimilar or the original drug before surgery to compare how the drugs move through the body and their safety. The goal is to see if the biosimilar can be a more affordable option without changing effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 258 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntary participation in the clinical study and signed the Informed Consent Form (ICF). * Male or female aged ≥ 18 years old at the time of signing the ICF; * Histologically confirmed invasive breast cancer, stage II-IIIC, Human Epidermal Growth Factor Receptor 2 (HER2) positive confirmed by central laboratory. * Participants agree to undergo surgery while meeting the criteria for surgery after neoadjuvant therapy. * Left ventricular ejection fraction (LVEF) at baseline ≥ 55%. * An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1. * Adequate major organ functions. * Women with child-bearing potential have a negative result of serum pregnancy test at screening period (within 7 days prior to the first dose) or if they are infertile, non- lactating, reproduction-age men and women following highly effective contraceptive measures until 7 months after last dose. Exclusion Criteria: * Stage IV breast cancer, bilateral breast cancer, or multicentric breast cancer. * History of other malignancy within 5 years. * Prior systemic therapy for breast cancer treatment or radiotherapy. * Patients with a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) who have received systemic therapy or radiotherapy to the ipsilateral breast. * Patients who have undergone excision biopsy of the primary tumor and/or axillary lymph nodes or lymph node dissection. * Have severe heart disease or medical conditions. * Participants with viral hepatitis or those with autoimmune hepatitis, sclerosing cholangitis, or liver cirrhosis. * Human Immunodeficiency Virus (HIV) infection, HIV antibody positive. * Daily use of corticosteroid treatment is required. * Sensitivity to any study medications or any of its ingredients or excipients. * Participants who underwent any major surgery within 28 days prior to the first dose. Or participants who have received local radiotherapy, radiofrequency ablation, or interventional therapy within 2 weeks prior to the first dose. * Received another interventional clinical trial therapy within 4 weeks prior to enrollment in the study, or intentionally participated in another interventional clinical trial during the entire study period. * Severe, uncontrolled systemic diseases that may currently interfere with the therapeutic plan. * Any other conditions which are inappropriate for the study in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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