A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorMediLink Therapeutics (Suzhou) Co., Ltd.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- YL202 should be intravenously infused
Treatment groups
180 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov