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RECRUITINGPHASE2

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

NCT06241846•MediLink Therapeutics (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Subjects who understand relevant information of the study prior to initiation of the study and voluntarily sign and date on the ICF.
•2. Age ≥ 18 years.
•3. Patients should meet the following conditions to be enrolled:
•* Histologically or cytologically confirmed prostate cancer. Note: The primary histological classification indicated by biopsy should be adenocarcinoma;
•* Meeting the following criteria for clinical diagnosis of mCRPC:
•
•1. Subjects who understand relevant information of the study prior to initiation of the study and voluntarily sign and date on the ICF.
•2. Age ≥ 18 years.
•3. Patients should meet the following conditions to be enrolled:
•• Histologically or cytologically confirmed prostate cancer. Note: The primary histological classification indicated by biopsy should be adenocarcinoma;
+20 more criteria

Exclusion Criteria

•1. Previously treated with drugs targeting B7H3.
•2. 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.
•3. Previously treated with topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
•4. The washout period of the previous anti-tumor therapy is considered insufficient.
•5. Patients received major surgery.
•6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
•7. Prior treatment with glucocorticoids for more than 28 consecutive days within 28 days prior to the first dose of the investigational drug.
•8. Patients received any live vaccine within 4 weeks prior to the first dose of the investigational drug, or plan to receive live vaccine during the study period.
•9. Have pathological long bone fracture, or the risk of pathological long bone fracture.
•10. Have meningeal metastasis or cancerous meningitis.
+14 more criteria

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

Key Dates

Start Date

February 22, 2024

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2029

Last Updated

August 27, 2025

Enrollment

100

ESTIMATED participants

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions

YL201 for Injection

DRUG

Contacts

Sasha Stann

CONTACT

06172408494 sasha@medilinkthera.com

Steve Chin, Ph.D.

CONTACT

06178719455 info@medilinkthera.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.

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68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

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