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Can a new antibody boost treatment for Hard-to-Treat HER2 breast cancer?

NCT ID NCT07824869

Disease control Sponsor: Shanghai Henlius Biotech Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

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.
Paused
Paused for now. It may or may not start again.
Ongoing
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 Results may not be published yet.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.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing whether adding an experimental drug called HLX22 to standard trastuzumab and chemotherapy helps people with locally advanced or metastatic HER2-positive breast cancer that has already been treated with a HER2 ADC. About 90 adults will receive either HLX22 or a placebo alongside trastuzumab and one of several chemotherapy drugs. The main goal is to see how many participants' tumors shrink or disappear, with safety and other outcomes also tracked.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HLX22, an experimental antibody drug given with trastuzumab and chemotherapy
What this could lead to
If it works, this could offer another option for people with advanced HER2-positive breast cancer whose disease has progressed after an ADC treatment.
What could go wrong
This is a small phase 2 trial, so it may not show a clear benefit or the results may not hold in larger studies. Adding HLX22 could also cause side effects that outweigh any benefit.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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: * 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.

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Conditions

The condition(s) this trial relates to.

breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

HER2 + breast cancer

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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