RecruitingPhase 2NCT06241846

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

A Multicenter, Open-Label, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Metastatic Castration-Resistant Prostate Cancer

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Enrollment

100 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Summary

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called YL201 in men with metastatic castration-resistant prostate cancer (mCRPC) — a type of prostate cancer that has spread to other parts of the body and continues to grow despite hormone therapy. The trial evaluates the drug's safety, effectiveness, and how the body processes it. **You may be eligible if...** - You are 18 or older with confirmed prostate cancer (adenocarcinoma type) - Your cancer has spread and continues to grow despite hormone therapy that has lowered testosterone to castrate levels - Your PSA level has risen on two consecutive tests, or imaging shows disease progression - You have adequate organ and bone marrow function **You may NOT be eligible if...** - You do not meet the criteria for castration-resistant prostate cancer - You have received certain prior treatments that conflict with the study protocol - Your organ function does not meet the required levels - You have other serious conditions that would make participation unsafe 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

DRUGYL201 for Injection

Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks on Day 1 or twice every 3 weeks on Day 1 and Day 8 during a 3-week (21-day) cycle.

Locations(24)

Anhui Provincial Hospital

Hefei, Anhui, China

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Hunan Cancer Hospital

Hunan, Changsha, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital of Huazhong University of Science and Technology Tongji Medical College

Wuhan, Hubei, China

Nanjing Drum Tower hospital

Nanjing, Jiangsu, China

Nantong Tumor Hospital

Nantong, Jiangsu, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Shandong Tumor Hospital

Jinan, Shandong, China

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Ningbo Yinzhou No.2 Hospital

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Fudan University Shanghai Cancer Center

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06241846

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