RecruitingPhase 2NCT06439771

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

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


Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Enrollment

180 participants

Start Date

Apr 23, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study tests YL202, a new antibody-drug conjugate that targets HER3 (a protein found on some cancer cells), in patients with advanced breast cancer — including both triple-negative and hormone receptor-positive subtypes — whose cancer has stopped responding to prior HER2 or TROP2 targeting treatments. **You may be eligible if...** - You have locally advanced or metastatic breast cancer that cannot be surgically cured - Your breast cancer is either triple-negative (HR-negative, HER2-negative) or HR-positive with HER2-low or zero expression - Your cancer has previously failed treatment with a HER2-targeting ADC or a TROP2-targeting ADC - You have at least one measurable tumor outside the brain - Your expected survival is at least 3 months - Your blood counts and organ function meet study requirements **You may NOT be eligible if...** - You have previously received a drug specifically targeting HER3 - You cannot tolerate topoisomerase I inhibitors - You have had major surgery within 4 weeks - You have had a prior bone marrow or organ transplant - You are on ongoing systemic steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGYL202 should be intravenously infused

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


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06439771


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