A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMediLink Therapeutics (Suzhou) Co., Ltd.

About this trial

This is a multicenter, open-label, phase II study of YL201 in China to evaluate the efficacy, safety, and PK characteristics of YL201 on mCRPC.

Eligibility criteria

Qualifiers

Subjects who understand relevant information of the study prior to initiation of the study and voluntarily sign and date on the ICF.

Age ≥ 18 years.

Histologically or cytologically confirmed prostate cancer. Note: The primary histological classification indicated by biopsy should be adenocarcinoma;

Subjects who understand relevant information of the study prior to initiation of the study and voluntarily sign and date on the ICF.

Disqualifiers

Previously treated with drugs targeting B7H3.

Currently participating in another clinical study, unless it is an observational (non-interventional) clinical study, or the patient is at the follow-up period of an interventional study.

Previously treated with topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.

The washout period of the previous anti-tumor therapy is considered insufficient.

Trial design

Treatments tested in this trial

  • YL201 for Injection

Treatment groups

100 Participants
are divided into 2 treatment groups