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

NCT06241846 | Recruiting Phase 2 FDA Drug

• 1 other identifier: YL201-CN-201-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Outcome Measures

Primary Outcomes (3)

• Objective response rate (ORR) by RECIST1.1 and PCWG3 criteria per investigators' review

  defined as percentage of participants with confirmed best overall response of confirmed complete response (CR) or partial response (PR) to treatment

  Approximately within 36 months

• Radiographic progression free survival (rPFS), and rPFS rate at 3/6 months by RECIST1.1 and PCWG3 criteria per investigators' review

  defined as the time from the date of first administration to first documented progressive disease (PD) per RECIST1.1 and PCWG3 or death from any cause, whichever occurs first.

  Approximately within 36 months

• Recommended dose of YL201 for the pivotal clinical trial.

  Approximately within 36 months

Secondary Outcomes (23)

• disease control Rate (DCR) by RECIST1.1 and PCWG3 criteria per investigators' review

  Approximately within 36 months

• To evaluate DoR by RECIST1.1 and PCWG3 criteria per investigators' review of YL201 in the treatment of mCRPC

  Approximately within 36 months

• To evaluate TTR of YL201 in the treatment of mCRPC

  Approximately within 36 months

• To evaluate DpR of YL201 in the treatment of mCRPC

  Approximately within 36 months

• To evaluate PSA50 response rate and PSA50 response rate at 12 weeks of YL201 in the treatment of mCRPC

  Approximately within 36 months

Study Arms (2)

Part 1

EXPERIMENTAL

To evaluate the safety and efficacy of YL201 in patients with mCRPC and to determine the recommended dose of YL201 for the pivotal clinical study (n ≈ 60)； Cohort 1: YL201 2.0 mg/kg iv Q3W ； Cohort 2: YL201 1.6 mg/kg iv Q3W； Cohort 3: YL201 2.4 mg/kg iv Q3W； Cohort 4: YL201 1.2 mg/kg iv D1, D8 Q3W； Cohort 5: YL201 1.0 mg/kg iv D1, D8, Q3W；

Drug: YL201 for Injection

Part2

EXPERIMENTAL

To evaluate the safety and efficacy of YL201 in patients with mCRPC and to determine the recommended dose of YL201 for the pivotal clinical study (n ≈ 40)； Recommended dose and method of administration

Drug: YL201 for Injection

Interventions

YL201 for Injection DRUG

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.

Part 1; Part2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
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• 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.
• 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:
• √Testosterone level after castration (a serum testosterone level of \<50 ng/dl or 1.7 nmol/L);
• Serum prostate specific antigen (PSA) progression (PSA \> 1 ng/mL and 2 consecutive increases in PSA with at least a 1-week interval \>50% from baseline), or PD by imaging (≥ 2 new bone lesions suggested by a bone scan according to PCWG3 criteria; and/or progression of soft tissue lesions suggested by computed tomography (CT) or nuclear magnetic resonance imaging (MRI) according to RECIST v1.1); meeting either or both criteria;
• Persistent luteinizing hormone-releasing hormone (LHRH) analogue castration (medical castration) or prior bilateral orchiectomy (surgical castration); surgical castration should be performed at least 3 months prior to enrollment, and medical castration is required from at least 3 months prior to the first dose and throughout the study for subjects not yet undertake bilateral orchiectomy; • Patients with progression on or intolerance to at least one prior novel hormone therapy (NHT) (e.g., enzalutamide, abiraterone, darolutamide, apalutamide, or rezvilutamide); • Prior therapy with no more than 2 lines of chemotherapy is allowed; • Patients with known previous prostate adenocarcinoma with a documented BRCA1/2 (germline or somatic) mutation should have received poly ADP ribose polymerase (PARP) inhibitor therapy (if available and tolerated);
• Patients with metastatic lesions confirmed by CT, MRI, or bone scan imaging within 28 days prior to the first dose.

You may not qualify if:

• 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.
• Patients received major surgery.
• Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
• Prior treatment with glucocorticoids for more than 28 consecutive days within 28 days prior to the first dose of the investigational drug.
• 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.
• Have pathological long bone fracture, or the risk of pathological long bone fracture.
• Have meningeal metastasis or cancerous meningitis.
• Have uncontrolled bladder outlet obstruction or urinary incontinence.
• Have brain metastasis or spinal cord compression.
• Patients with uncontrolled or clinically significant cardiovascular diseases.
• Clinically significant complicated pulmonary disorders.
• Diagnosed with Gilbert's syndrome.

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (24)

Anhui Provincial Hospital

Hefei, Anhui, China

NOT YET RECRUITING

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

NOT YET RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Hunan Cancer Hospital

Hunan, Changsha, China

NOT YET RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 250117, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 250117, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 250117, China

NOT YET RECRUITING

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

Wuhan, Hubei, 250117, China

NOT YET RECRUITING

Nanjing Drum Tower hospital

Nanjing, Jiangsu, China

NOT YET RECRUITING

Nantong Tumor Hospital

Nantong, Jiangsu, China

NOT YET RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, 250117, China

NOT YET RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 250117, China

NOT YET RECRUITING

Shandong Tumor Hospital

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 250117, China

NOT YET RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 250117, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 250117, China

NOT YET RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 250117, China

NOT YET RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 250117, China

NOT YET RECRUITING

Ningbo Yinzhou No.2 Hospital

Ningbo, Zhejiang, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Sasha Stann

CONTACT

06172408494; sasha@medilinkthera.com

Steve Chin, Ph.D.

CONTACT

06178719455; info@medilinkthera.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: February 22, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: August 27, 2025

Record last verified: 2025-07

Locations

CN (24)