Metastatic Castration-resistant Prostate Cancer (mCRPC)Phase 2NCT06241846
A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC
A Phase 2 study testing YL201 for Injection in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by MediLink Therapeutics (Suzhou) Co., Ltd. at 24 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- What is being tested?
- YL201 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 24 sitesChina
- Study dates
- 22 Feb 2024to Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients with archived or fresh tumor tissue samples. Patients who cannot provide tumor samples or cannot provide sufficient samples may be enrolled in this study after considering specific circumstances and discussions with the Sponsor.
- Fresh tumor tissue samples (formalin-fixed, paraffin-embedded (FFPE) tumor blocks or FFPE sections) should be provided for retrospective detection of B7H3 expression by the central laboratory using the immunohistochemistry [IHC] method; if fresh tumor tissue samples are not available, FFPE tumor blocks previously archived are acceptable, and fresh FFPE sections should be prepared within 2 weeks.
- Eastern cooperative oncology group performance status (ECOG PS) score of 0 or 1.
- The function of organs and bone marrow meets the requirements within 7 days prior to the first dose, which is defined as follows:
- Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion or erythropoietin treatment within 14 days prior to the first dose);
- Absolute neutrophil count (ANC) ≥ 1.5×109/L (no treatment with granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor within 14 days prior to the first dose);
- Platelet count (PLT) ≥ 100×109/L (no platelet transfusion, thrombopoietin, or interleukin-11 within 14 days prior to the first dose);
- Total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN) in the absence of obvious liver metastasis, or ≤ 3×ULN in the presence of liver metastasis;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN in the absence of obvious liver metastasis or ≤ 5×ULN in the presence of liver metastasis;
- Serum albumin (ALB) ≥ 30 g/L;
- Creatinine clearance calculated using Cockcroft-Gault formula ≥ 50 mL/min or the creatinine ≤ 1.5×ULN;
- Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN, except for patients who are on anticoagulant therapy. In this case, a stable anticoagulant regimen should be maintained with APTT and INR controlled within the range deemed appropriate by the investigator.
- Patients must agree to adopt highly effective contraceptive measures from screening, throughout the study period, and within at least 6 months after the last dose of the investigational drug.
- Expected survival ≥ 6 months.
- Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.
Who cannot join
- 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.
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- 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.
- Accompanying uncontrolled effusion in the third space requiring repeated drainage.
- Medical history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose, or active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may cause hemorrhage or perforation in the opinion of the investigator.
- Active serious infection (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] ≥ 3) within 4 weeks prior to the first dose.
- Known human immunodeficiency virus (HIV) infection.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Diagnosed with the other malignancies that may change the expected survival or affect the response evaluation.
- Unresolved toxicity of previous anti-tumor therapy.
- History of severe hypersensitivity to inactive ingredients in the drug substance and drug product or other monoclonal antibodies.
- Have any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the subject ability to sign the ICF, adversely affect the subject ability to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance/alcohol abuse, in the opinion of the investigator.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites, 24 recruiting
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Site Coordinator
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Site Coordinator
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 250117
Coordinator Clinical operation director, RA@medilinkthera.com
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 250117
Coordinator Clinical operation director, RA@medilinkthera.com
- Not yet recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
Site Coordinator
- Not yet recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 250117
Coordinator Clinical operation director, RA@medilinkthera.com
- Not yet recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 250117
Coordinator Clinical operation director, RA@medilinkthera.com
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 250117
Coordinator Clinical operation director, RA@medilinkthera.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 250117
Coordinator Clinical operation director, RA@medilinkthera.com
- Not yet recruiting
Anhui Provincial Hospital
Hefei, Anhui
Site Coordinator
- Not yet recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Coordinator Clinical operation director, RA@medilinkthera.com
- Not yet recruiting
Hunan Cancer Hospital
Hunan, Changsha
Site Coordinator
- Not yet recruiting
Shandong Tumor Hospital
Jinan, Shandong, 250117
Coordinator Clinical operation director, RA@medilinkthera.com
- Not yet recruiting
Nanjing Drum Tower hospital
Nanjing, Jiangsu
Site Coordinator
- Not yet recruiting
Nantong Tumor Hospital
Nantong, Jiangsu
Site Coordinator
- Recruiting
Ningbo Yinzhou No.2 Hospital
Ningbo, Zhejiang
Site Coordinator
- Not yet recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 250117
Coordinator Clinical operation director, RA@medilinkthera.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Site Coordinator
- Not yet recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 250117
Coordinator Clinical operation director, RA@medilinkthera.com
- Not yet recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 250117
Coordinator Clinical operation director, RA@medilinkthera.com
- Not yet recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
Site Coordinator
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Site Coordinator
- Not yet recruiting
Union Hospital of Huazhong University of Science and Technology Tongji Medical College
Wuhan, Hubei, 250117
Coordinator Clinical operation director, RA@medilinkthera.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 250117
Coordinator Clinical operation director, RA@medilinkthera.com
About this study
Official title: A Multicenter, Open-Label, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Metastatic Castration-Resistant Prostate Cancer
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.
- Being tested
- YL201 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL201 for InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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； Receives: 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 Receives: Drug: YL201 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Approximately within 36 months
Recommended dose of YL201 for the pivotal clinical trial.
Measured: Approximately within 36 months
Secondary outcomes (23)
disease control Rate (DCR) by RECIST1.1 and PCWG3 criteria per investigators' review
Disease control rate
Measured: Approximately within 36 months
To evaluate DoR by RECIST1.1 and PCWG3 criteria per investigators' review of YL201 in the treatment of mCRPC
Duration of rasponse
Measured: Approximately within 36 months
To evaluate TTR of YL201 in the treatment of mCRPC
Time to Objective response
Measured: Approximately within 36 months
To evaluate DpR of YL201 in the treatment of mCRPC
deepness of response
Measured: Approximately within 36 months
To evaluate PSA50 response rate and PSA50 response rate at 12 weeks of YL201 in the treatment of mCRPC
PSA50 response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%.
Measured: Approximately within 36 months
To evaluate TTPR of YL201 in the treatment of mCRPC
time to PSA response
Measured: Approximately within 36 months
To evaluate PDoR of YL201 in the treatment of mCRPC
PSA duration of response
Measured: Approximately within 36 months
To evaluate PDpR of YL201 in the treatment of mCRPC
PSA deepness of response
Measured: Approximately within 36 months
To evaluate TTPP of YL201 in the treatment of mCRPC
time to PSA progression
Measured: Approximately within 36 months
To evaluate TFST of YL201 in the treatment of mCRPC
time to first subsequent therapy
Measured: Approximately within 36 months
To evaluate rPFS of YL201 in the treatment of mCRPC
Radiographic Progression Free Survival
Measured: Approximately within 36 months
To evaluate OS of YL201 in the treatment of mCRPC
overall survival
Measured: Approximately within 36 months
To evaluate time to first symptomatic skeletal event of YL201 in the treatment of mCRPC
assessed by investigator according to RECIST v1.1 and PCWG3 criteria
Measured: Approximately within 36 months
Expression of B7H3 in tumor tissue at baseline and the relationship with the efficacy of YL201.
Measured: Approximately within 36 months
Number of participants with AEs, SAEs, and SAEs leading to study treatment interruption or discontinuation.
adverse event, serious adverse event
Measured: Approximately within 36 months
To evaluate the AUC of YL201
the area under curve: AUC is the total amount of YL201 in bloodstream after drug administration
Measured: Approximately within 36 months
To evaluate the Cmax of YL201
Maximum concentration: The highest measured concentration of YL201 in the bloodstream.
Measured: Approximately within 36 months
To evaluate the Ctrough of YL201
trough concentration
Measured: Approximately within 36 months
To evaluate the CL of YL201
Clearance: defined as the amount of drug removed from the bloodstream by the body per unit of time
Measured: Approximately within 36 months
To evaluate the Vd of YL201
volume of distribution
Measured: Approximately within 36 months
To evaluate the T1/2 of YL201
Terminal half-life: defined as the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%
Measured: Approximately within 36 months
To evaluate the E-R relationship of YL201
exposure-response
Measured: Approximately within 36 months
To evaluate the immunogenicity of YL201
Measured: Approximately within 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start22 Feb 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241846
- Sponsor's protocol ID
- YL201-CN-201-01
- Status last verified
- Jul 2025
- First submitted
- 28 Jan 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06241846
- Acronym / sponsor ID
- YL201-CN-201-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: YL201 for InjectionTo 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； |
| Part2 | Experimental | Drug: YL201 for InjectionTo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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:
- <!-- -->
- Subjects who understand relevant information of the study prior to initiation of the study and voluntarily sign and date on the ICF.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YL201 for InjectionPatients 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. | Drug | Part 1, Part2 |
Primary outcome
Objective response rate (ORR) by RECIST1.1 and PCWG3 criteria per investigators' review
Time frame: Approximately within 36 months
defined as percentage of participants with confirmed best overall response of confirmed complete response (CR) or partial response (PR) to treatment
Radiographic progression free survival (rPFS), and rPFS rate at 3/6 months by RECIST1.1 and PCWG3 criteria per investigators' review
Time frame: Approximately within 36 months
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.
Recommended dose of YL201 for the pivotal clinical trial.
Time frame: Approximately within 36 months
23 secondary outcomes
disease control Rate (DCR) by RECIST1.1 and PCWG3 criteria per investigators' review
Time frame: Approximately within 36 months
To evaluate DoR by RECIST1.1 and PCWG3 criteria per investigators' review of YL201 in the treatment of mCRPC
Time frame: Approximately within 36 months
To evaluate TTR of YL201 in the treatment of mCRPC
Time frame: Approximately within 36 months
To evaluate DpR of YL201 in the treatment of mCRPC
Time frame: Approximately within 36 months
To evaluate PSA50 response rate and PSA50 response rate at 12 weeks of YL201 in the treatment of mCRPC
Time frame: Approximately within 36 months
To evaluate TTPR of YL201 in the treatment of mCRPC
Time frame: Approximately within 36 months
To evaluate PDoR of YL201 in the treatment of mCRPC
Time frame: Approximately within 36 months
To evaluate PDpR of YL201 in the treatment of mCRPC
Time frame: Approximately within 36 months
To evaluate TTPP of YL201 in the treatment of mCRPC
Time frame: Approximately within 36 months
To evaluate TFST of YL201 in the treatment of mCRPC
Time frame: Approximately within 36 months
To evaluate rPFS of YL201 in the treatment of mCRPC
Time frame: Approximately within 36 months
To evaluate OS of YL201 in the treatment of mCRPC
Time frame: Approximately within 36 months
To evaluate time to first symptomatic skeletal event of YL201 in the treatment of mCRPC
Time frame: Approximately within 36 months
Expression of B7H3 in tumor tissue at baseline and the relationship with the efficacy of YL201.
Time frame: Approximately within 36 months
Number of participants with AEs, SAEs, and SAEs leading to study treatment interruption or discontinuation.
Time frame: Approximately within 36 months
To evaluate the AUC of YL201
Time frame: Approximately within 36 months
To evaluate the Cmax of YL201
Time frame: Approximately within 36 months
To evaluate the Ctrough of YL201
Time frame: Approximately within 36 months
To evaluate the CL of YL201
Time frame: Approximately within 36 months
To evaluate the Vd of YL201
Time frame: Approximately within 36 months
To evaluate the T1/2 of YL201
Time frame: Approximately within 36 months
To evaluate the E-R relationship of YL201
Time frame: Approximately within 36 months
To evaluate the immunogenicity of YL201
Time frame: Approximately within 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YL201 for Injection in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by MediLink Therapeutics (Suzhou) Co., Ltd. at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sasha Stann (06172408494, sasha@medilinkthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) by RECIST1.1 and PCWG3 criteria per investigators' review (time frame: Approximately within 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.