New drug YL202 targets Hard-to-Treat breast cancers

NCT ID NCT06439771

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This phase 2 trial tests an experimental drug called YL202 in people with advanced or metastatic breast cancer that has not responded to other treatments. The study includes patients with triple-negative breast cancer (TNBC) or hormone receptor-positive, HER2-zero or HER2-low tumors. Researchers aim to see how well YL202 shrinks tumors and to check its safety.

What this could mean

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

Active substance
an experimental antibody-drug conjugate called YL202
What this could lead to
If successful, YL202 could offer a new treatment option for people with advanced breast cancers that have limited effective therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not confirm effectiveness. The drug may cause side effects or fail to shrink tumors in many patients.

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 180 people

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

Started

Apr 2024

Expected to finish

Jul 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 to 75 years

Sex

Female participants only

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: 1. Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form. 2. Patients with locally advanced or metastatic disease (according to the UICC and AJCC staging system \[Version 8\]) who are not candidates for curative surgery or radiotherapy. 3. Patients who are pathologically confirmed advanced/unresectable or metastatic breast cancer with HR-negative and HER2-negative,. 4. Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression. 5. Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC. 6. Have at least 1 extracranial measurable lesion as a target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 7. Have Adequate organ and bone marrow function within 7 days prior to the first dose. 8. Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug. 9. Have a expected survival ≥ 3 months. 10. Have ability and willingness to comply with protocol-specified visits and procedures. Exclusion Criteria: 1. Have prior treatment with an agent targeting HER3. 2. Have prior intolerance to treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor. 3. Have been enrolled in another clinical study concurrently unless it is an observational clinical study or in the follow-up phase of an interventional study. 4. Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug. 5. Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study. 6. Have prior allogeneic bone marrow transplant or prior solid organ transplant. 7. Have received treatment with systemic steroids. 8. Have received any live vaccine within 4 weeks prior to the first dose of study drug or intend to receive a live vaccine during the study. 9. Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression. 10. Brain metastases with the exceptions. 11. Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease. 12. Have clinically significant concomitant pulmonary diseases. 13. Have a diagnosis of Gilbert's syndrome. 14. Have pleural effusion, abdominal effusion. 15. Have a history of gastrointestinal perforation and or fistula within 6 months prior to the first dose. 16. Have serious infection. 17. Patients with human immunodeficiency virus (HIV) infection. 18. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 19. Have any other primary malignancy within 5 years prior to the first dose of study drug. 20. Have unresolved toxicities from prior anticancer therapy. 21. Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies. 22. Lactating women, or women who are confirmed to be pregnant by pregnancy test within 3 days prior to the first dose.

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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.

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 250117, China

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