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New hope for hard-to-treat breast cancer: combo therapy enters human trials

NCT ID NCT07336771

Disease control Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new two-drug combination (JSKN016 plus D-0502) in 60 people with advanced hormone receptor-positive, HER2-negative breast cancer whose disease worsened after standard hormone therapy. The goal is to see if the combination is safe and shrinks tumors. Participants receive the drugs either every 2 or 3 weeks by IV plus a daily pill.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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: * Age ≥18 years * Histologically or cytologically confirmed locally advanced or metastatic HR-positive, HER2-negative breast cancer * HR-positive defined as ER and/or PR ≥1% by IHC * HER2-negative per ASCO/CAP guidelines * At least one measurable extracranial lesion per RECIST v1.1 * ECOG performance status 0-1 * Prior progression on CDK4/6 inhibitor plus endocrine therapy * Adequate organ and cardiac function * Postmenopausal women, or premenopausal women receiving ovarian function suppression Exclusion Criteria: * Active or untreated CNS metastases * Prior treatment with ADCs containing topoisomerase I inhibitor payloads * Active interstitial lung disease or pneumonitis * Uncontrolled cardiovascular disease or active infection * Prior malignancy within 5 years (with specific exceptions) * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Locally advanced breast cancer (LABC) Metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer center

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.