YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer

A Randomized, Open-label, Multicenter, Phase 3 Study of YL202 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy

The study will evaluate the safety and efficacy of YL202, when compared with treatment of physician's choice (eribulin, capecitabine, vinorelbine, gemcitabine or sacituzumab govitecan) in participants with unresectable locally advanced, recurrent or metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer who had failed at least one line of chemotherapy.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced or Metastatic Breast Cancer
• Intervention / Treatment: Drug: Eribulin; Drug: Vinorelbine; Drug: YL202; Drug: Capecitabine; Drug: Gemcitabine; Drug: Sacituzumab govitecan

• Study Type: Interventional
• Enrollment (Estimated): 376
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Medilink Study Team; Phone Number: +86 0512-62858368; Email: clinicaltrials@medilinkthera.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201321
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Study Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. Histologically and/or cytologically confirmed locally advanced or metastatic HR+/HER2- breast cancer who are not candidates for curative surgery or radiotherapy.
3. Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage.
4. Have at least 1 extracranial measurable lesion as a target lesion per RECIST 1.1.
5. Tumor tissue samples can be provided at the time of diagnosis of locally advanced or metastatic tumors.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 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 treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.
3. Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.
4. 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.
5. Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.
6. Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.
7. Have clinically significant concomitant pulmonary diseases.
8. Have uncontrolled pleural effusion, abdominal effusion.
9. Have serious infection within 4 weeks prior to the first dose.
10. Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YL202	Drug: YL202; IV infusion on day 1 of each 21 day cycle
Active Comparator: Treatment of Physician's Choice (TPC); TPC,Eribulin, capecitabine, gemcitabine, vinorelbine or sacituzumab govitecan	Drug: Eribulin; 1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle; Drug: Vinorelbine; 25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle; Drug: Capecitabine; 1000 or 1250 mg/m2, po, bid, from day 1 to Day 14 of each 21 day cycle; Drug: Gemcitabine; 1000 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle; Drug: Sacituzumab govitecan; 10 mg/kg, IV infusion on day 1 and Day 8 of each 21 day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) assessed by BIRC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	PFS is defined as time from randomization until disease progression or death due to any cause.	up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as time from randomization until the date of death due to any cause.	up to 36 months
Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1	PFS is defined as time from randomization until disease progression or death due to any cause.	up to 18 months
Objective Response Rate (ORR)	Objective response rate is defined as the proportion of participants who have a CR or PR, as determined by the BICR/Investigator assessment, per RECIST 1.1.	up to 18 months
Duration of Response (DoR)	Duration of response is defined as the time from the date of first documented confirmed response until disease progression, as determined by BICR/Investigator assessment or death due to any cause.	up to 18 months
Disease Control Rate (DCR)	DCR is defined as the percentage of participants who have a CR, PR or SD, per RECIST 1.1, as determined by BICR/Investigator assessment, per RECIST 1.1.	up to 18 months
Adverse Events (AEs)	Incidence and severity of AEs and clinically significant abnormal laboratory findings.	up to 36 months

Collaborators and Investigators

• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Alkaloids; Indoles; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indolizidines; Indolizines; Deoxyribonucleosides; Fluorouracil; Capecitabine; Vinorelbine; Gemcitabine; eribulin; sacituzumab govitecan
• Other Study ID Numbers: YL202-CN-302-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No