Trial Title:
A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC
NCT ID:
NCT06241846
Condition:
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
YL201 for Injection
Description:
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.
Arm group label:
Part 1
Arm group label:
Part2
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.
Criteria for eligibility:
Criteria:
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;
• 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);
4. Patients with metastatic lesions confirmed by CT, MRI, or bone scan imaging within
28 days prior to the first dose.
5. 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.
6. Eastern cooperative oncology group performance status (ECOG PS) score of 0 or 1.
7. 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.
8. 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.
9. Expected survival ≥ 6 months.
10. Be capable of and willing to comply with the visits and procedures stipulated in the
study protocol.
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.
11. Have uncontrolled bladder outlet obstruction or urinary incontinence.
12. Have brain metastasis or spinal cord compression.
13. Patients with uncontrolled or clinically significant cardiovascular diseases.
14. Clinically significant complicated pulmonary disorders.
15. Diagnosed with Gilbert's syndrome.
16. Accompanying uncontrolled effusion in the third space requiring repeated drainage.
17. 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.
18. Active serious infection (National Cancer Institute Common Terminology Criteria for
Adverse Events [NCI CTCAE] ≥ 3) within 4 weeks prior to the first dose.
19. Known human immunodeficiency virus (HIV) infection.
20. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
21. Diagnosed with the other malignancies that may change the expected survival or
affect the response evaluation.
22. Unresolved toxicity of previous anti-tumor therapy.
23. History of severe hypersensitivity to inactive ingredients in the drug substance and
drug product or other monoclonal antibodies.
24. 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
The Second Affiliated Hospital of Anhui Medical University
Address:
City:
Hefei
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Peking University First Hospital
Address:
City:
Peking
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Peking University Third Hospital
Address:
City:
Peking
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Hunan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Union Hospital of Huazhong University of Science and Technology Tongji Medical College
Address:
City:
Wuhan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Nanjing Drum Tower hospital
Address:
City:
Nanjing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Nantong Tumor Hospital
Address:
City:
Nantong
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Liaoning Cancer Hospital
Address:
City:
Shenyang
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
The First Affiliated Hospital of China Medical University
Address:
City:
Shenyang
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Shandong Tumor Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Zhongshan Hospital of Fudan University
Address:
City:
Shanghai
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Sichuan Provincial People's Hospital
Address:
City:
Chengdu
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
The Second Hospital of Tianjin Medical University
Address:
City:
Tianjin
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Zhejiang Provincial People's Hospital
Address:
City:
Hangzhou
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Ningbo Yinzhou No.2 Hospital
Address:
City:
Ningbo
Country:
China
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Start date:
February 22, 2024
Completion date:
February 2029
Lead sponsor:
Agency:
MediLink Therapeutics (Suzhou) Co., Ltd.
Agency class:
Industry
Source:
MediLink Therapeutics (Suzhou) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06241846
