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Locally Advanced or Metastatic Breast CancerPhase 2NCT06439771

A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC

A Phase 2 study testing YL202 should be intravenously infused in people with Locally Advanced or Metastatic Breast Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
YL202 should be intravenously infused
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
23 Apr 2024to 29 Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.
  • 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.
  • Patients who are pathologically confirmed advanced/unresectable or metastatic breast cancer with HR-negative and HER2-negative,.
  • Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression.
  • Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC.
  • Have at least 1 extracranial measurable lesion as a target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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  • Have Adequate organ and bone marrow function within 7 days prior to the first dose.
  • 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.
  • Have a expected survival ≥ 3 months.
  • Have ability and willingness to comply with protocol-specified visits and procedures.

Who cannot join

  • Have prior treatment with an agent targeting HER3.
  • Have prior intolerance to treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.
  • 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.
  • Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.
  • 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.
  • Have prior allogeneic bone marrow transplant or prior solid organ transplant.
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  • Have received treatment with systemic steroids.
  • 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.
  • Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.
  • Brain metastases with the exceptions.
  • Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.
  • Have clinically significant concomitant pulmonary diseases.
  • Have a diagnosis of Gilbert's syndrome.
  • Have pleural effusion, abdominal effusion.
  • Have a history of gastrointestinal perforation and or fistula within 6 months prior to the first dose.
  • Have serious infection.
  • Patients with human immunodeficiency virus (HIV) infection.
  • Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Have any other primary malignancy within 5 years prior to the first dose of study drug.
  • Have unresolved toxicities from prior anticancer therapy.
  • Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.
  • Lactating women, or women who are confirmed to be pregnant by pregnancy test within 3 days prior to the first dose.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

MediLink Study Team contact

+86 512 62858368

clinicaltrials@medilinkthera.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 250117

    Study Coordinator

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With Locally Advanced or Metastatic Breast Cancer With TNBC, HR-Positive, HER2-Zero-expression or HER2-Low-expression

This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression

Being tested
YL202 should be intravenously infused
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YL202 should be intravenously infusedDrug

    For each patient, YL202 should be intravenously infused over 60±10 min.

Study groups in NCT06439771
Study groupRoleWhat they receive
Experimental: Corhort AExperimentalYL202 is provided as the lyophilized powder, 200 mg/vial. Triple-negative breast cancer (TNBC) patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
Receives: Drug: YL202 should be intravenously infused
Experimental: Corhort BExperimentalYL202 is provided as the lyophilized powder, 200 mg/vial. HR-positive breast cancer with HER2-Zero-expression and HER2-Low-expression patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
Receives: Drug: YL202 should be intravenously infused
Experimental: Corhort CExperimentalYL202 is provided as the lyophilized powder, 200 mg/vial. Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC (excluding HER2+ patients, ie, HER2 IHC 3+ or IHC 2+/ISH+ patients) will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
Receives: Drug: YL202 should be intravenously infused

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR assessed according to RECIST v1.1

    ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).

    Measured: By the end of trial date, approximately within 36 months

  2. Determination of the recommended dose of YL202 in the pivotal clinical study

    Measured: By the end of trial date, approximately within 36 months

Secondary outcomes (16)

  1. Progression-free survival (PFS) assessed according to RECIST v1.1

    Measured: By the end of trial date, approximately within 36 months

  2. Clinical benefit rate (CBR) assessed based on RECIST v1.1

    Measured: By the end of trial date, approximately within 36 months

  3. Depth of response (DpR) assessed based on RECIST v1.1

    Measured: By the end of trial date, approximately within 36 months

  4. Disease control rate (DCR) assessed based on RECIST v1.1

    Measured: By the end of trial date, approximately within 36 months

  5. Duration of response (DOR) assessed based on RECIST v1.1

    Measured: By the end of trial date, approximately within 36 months

  6. Time to response (TTR) assessed based on RECIST v1.1

    Measured: By the end of trial date, approximately within 36 months

  7. Evaluate the overall survival (OS)

    Measured: By the end of trial date, approximately within 36 months

  8. Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment

    Measured: Approximately within 36 months

  9. Characterize the PK parameter AUC

    steady-state area under curve (AUC)

    Measured: Approximately within 36 months

  10. Characterize the PK parameter Cmax

    peak concentration (Cmax)

    Measured: Approximately within 36 months

  11. Characterize the PK parameter Ctrough

    trough concentration (Ctrough)

    Measured: Approximately within 36 months

  12. Characterize the PK parameter CL

    clearance (CL)

    Measured: Approximately within 36 months

  13. Characterize the PK parameter Vd

    volume of distribution (Vd)

    Measured: Approximately within 36 months

  14. Characterize the PK parameter t1/2

    half-life (t1/2)

    Measured: Approximately within 36 months

  15. Incidence of anti-YL202 antibody

    Measured: Approximately within 36 months

  16. Evaluate the corelaton between different levels of HER3 expression and the sum of CR rate, PR rate and SD rate

    Measured: Approximately within 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2024
  2. Study start23 Apr 2024
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion29 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06439771
Sponsor's protocol ID
YL202-CN-202-01
Status last verified
Oct 2026
First submitted
16 May 2024
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YL202 should be intravenously infused in people with Locally Advanced or Metastatic Breast Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MediLink Study Team (+86 512 62858368, clinicaltrials@medilinkthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR assessed according to RECIST v1.1 (time frame: By the end of trial date, approximately within 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06439771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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