Actively Recruiting
A Multicenter, Open-Label Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Metastatic Castration-Resistant Prostate Cancer
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2025-08-27
100
Participants Needed
24
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating YL201, a drug being studied for men with metastatic castration-resistant prostate cancer (mCRPC), in an open-label, multicenter phase II trial in China. The study aims to assess the safety, effectiveness, and how the body processes YL201 in this patient group. This research includes patients who have progressed despite prior hormone therapies and may have received limited chemotherapy. The study is sponsored by MediLink Therapeutics (Suzhou) Co., Ltd. Participants will receive YL201 through intravenous infusion every three weeks, with dosing schedules varying between once or twice per cycle depending on the group. There are multiple dosing cohorts testing different amounts and frequencies of YL201 to find the best dose for future studies. The trial includes about 100 patients divided into initial groups receiving specific doses and a later group receiving the recommended dose and administration method. During the study, participants will undergo regular assessments including imaging scans to measure tumor response and progression, blood tests to monitor drug levels and side effects, and evaluations of prostate-specific antigen (PSA) levels. Researchers will track objective response rates, progression-free survival, and safety outcomes over approximately 36 months. Tumor tissue analysis for B7H3 expression and monitoring for adverse events will also be part of the study. Participants must comply with scheduled visits and procedures throughout the trial.
CONDITIONS
Brief Title
A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study information and voluntarily sign the informed consent form.
- Male aged 18 years or older.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Clinical diagnosis of metastatic castration-resistant prostate cancer with serum testosterone <50 ng/dl or 1.7 nmol/L.
- Evidence of disease progression by PSA or imaging criteria.
- Ongoing medical castration or prior bilateral orchiectomy at least 3 months before enrollment.
- Progression on or intolerance to at least one prior novel hormone therapy.
- Prior chemotherapy limited to no more than 2 lines.
- For patients with BRCA1/2 mutation, prior PARP inhibitor therapy if available and tolerated.
- Metastatic lesions confirmed by imaging within 28 days prior to first dose.
- Provide archived or fresh tumor tissue samples for B7H3 expression analysis.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ and bone marrow function within 7 days prior to first dose as specified.
- Agree to use highly effective contraception during the study and for at least 6 months after last dose.
- Expected survival of at least 6 months.
- Willing and able to comply with study visits and procedures.
You will not qualify if you...
- Prior treatment with drugs targeting B7H3.
- Current participation in another interventional clinical study.
- Prior treatment with topoisomerase I inhibitors or ADCs containing these inhibitors.
- Insufficient washout period from previous anti-tumor therapy.
- Recent major surgery.
- History of allogeneic bone marrow or solid organ transplantation.
- Prolonged glucocorticoid use within 28 days prior to first dose.
- Receipt of any live vaccine within 4 weeks prior to first dose or planned during study.
- Pathological long bone fracture or risk thereof.
- Presence of meningeal metastasis or cancerous meningitis.
- Uncontrolled bladder outlet obstruction or urinary incontinence.
- Brain metastasis or spinal cord compression.
- Uncontrolled or significant cardiovascular disease.
- Significant complicated pulmonary disorders.
- Diagnosis of Gilbert's syndrome.
- Uncontrolled effusion requiring repeated drainage.
- Recent gastrointestinal perforation, fistula, or active serious GI diseases.
- Active serious infection within 4 weeks prior to first dose.
- Known HIV infection.
- Active hepatitis B or C infection.
- Other malignancies affecting survival or response evaluation.
- Unresolved toxicity from previous anti-tumor therapy.
- Severe hypersensitivity to drug components or similar antibodies.
- Any condition interfering with informed consent, participation, or study result interpretation, including mental illness or substance abuse as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 36 months
Participants receive YL201 drug treatment by intravenous infusion once every 3 weeks on Day 1 or twice every 3 weeks on Day 1 and Day 8 during each 3-week cycle. Treatment continues as per protocol to evaluate safety, efficacy, and pharmacokinetics.
Infusions every 3 weeks with 1 or 2 visits per cycle
Trial Site Locations
Total: 24 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China
Not Yet Recruiting
2
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Not Yet Recruiting
3
Peking University First Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
4
Peking University Third Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
5
Hunan Cancer Hospital
Hunan, Changsha, China
Not Yet Recruiting
6
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
7
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 250117
Not Yet Recruiting
8
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 250117
Not Yet Recruiting
9
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 250117
Not Yet Recruiting
10
Union Hospital of Huazhong University of Science and Technology Tongji Medical College
Wuhan, Hubei, China, 250117
Not Yet Recruiting
11
Nanjing Drum Tower hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
12
Nantong Tumor Hospital
Nantong, Jiangsu, China
Not Yet Recruiting
13
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 250117
Not Yet Recruiting
14
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 250117
Not Yet Recruiting
15
Shandong Tumor Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
16
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 250117
Not Yet Recruiting
17
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 250117
Not Yet Recruiting
18
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 250117
Not Yet Recruiting
19
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
20
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 250117
Not Yet Recruiting
21
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 250117
Not Yet Recruiting
22
Ningbo Yinzhou No.2 Hospital
Ningbo, Zhejiang, China
Actively Recruiting
23
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Not Yet Recruiting
24
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
S
Sasha Stann
S
Steve Chin, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here