Actively Recruiting
A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2025-08-27
100
Participants Needed
24
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Be 18 years of age or older
- Have histologically or cytologically confirmed prostate adenocarcinoma
- Meet clinical diagnosis criteria for metastatic castration-resistant prostate cancer, including low serum testosterone levels and disease progression
- Have persistent medical or surgical castration
- Have experienced progression or intolerance to at least one prior novel hormone therapy
- Have received no more than two lines of chemotherapy
- If BRCA1/2 mutation positive, have received PARP inhibitor therapy if available and tolerated
- Have metastatic lesions confirmed by imaging within 28 days prior to first dose
- Provide archived or fresh tumor tissue samples for B7H3 expression testing, or be evaluated for special enrollment circumstances
- Have an ECOG performance status score of 0 or 1
- Meet specific organ and bone marrow function requirements within 7 days prior to first dose
- Agree to use highly effective contraception from screening through at least 6 months after last dose
- Have an expected survival of at least 6 months
- Be able and willing to comply with study visits and procedures
You will not qualify if you...
- Previously treated with drugs targeting B7H3
- Currently participating in another interventional clinical study (observational studies allowed)
- Previously treated with topoisomerase I inhibitors or antibody-drug conjugates containing them
- Insufficient washout period from prior anti-tumor therapy
- Recent major surgery
- Prior allogeneic bone marrow or solid organ transplantation
- Use of glucocorticoids for more than 28 consecutive days within 28 days before first dose
- Received any live vaccine within 4 weeks prior to first dose or plans to receive one during the study
- Have pathological long bone fracture or risk thereof
- Have meningeal metastasis or cancerous meningitis
- Uncontrolled bladder outlet obstruction or urinary incontinence
- Brain metastasis or spinal cord compression
- Uncontrolled or clinically significant cardiovascular disease
- Significant complicated lung disorders
- Diagnosed with Gilbert's syndrome
- Uncontrolled third space effusion requiring repeated drainage
- Recent gastrointestinal perforation, fistula, or active serious gastrointestinal 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 prior anti-tumor therapy
- Severe hypersensitivity to drug components or similar monoclonal antibodies
- Any condition interfering with informed consent or study participation, 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
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
CONTACT
S
Steve Chin, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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