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

ConditionLocally Advanced or Metastatic Breast Cancer

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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

Treatment groups

180 Participants

are divided into 3 treatment groups

Group A: Experimental: Corhort AExperimental treatment 1 intervention

Group B: Experimental: Corhort BExperimental treatment 1 intervention

Group C: Experimental: Corhort CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame