Phase
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Urologic Cancer
Treatment
YL201 for Injection
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects who understand relevant information of the study prior to initiation of thestudy 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 primaryhistological classification indicated by biopsy should be adenocarcinoma;
Meeting the following criteria for clinical diagnosis of mCRPC:
Subjects who understand relevant information of the study prior to initiation of thestudy 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 primaryhistological 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 1.7nmol/L);
Serum prostate specific antigen (PSA) progression (PSA > 1 ng/mL and 2consecutive increases in PSA with at least a 1-week interval >50% frombaseline), or PD by imaging (≥ 2 new bone lesions suggested by a bone scanaccording to PCWG3 criteria; and/or progression of soft tissue lesionssuggested 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 firstdose and throughout the study for subjects not yet undertake bilateralorchiectomy; • Patients with progression on or intolerance to at least oneprior 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 prostateadenocarcinoma with a documented BRCA1/2 (germline or somatic) mutation shouldhave received poly ADP ribose polymerase (PARP) inhibitor therapy (if availableand 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 providetumor samples or cannot provide sufficient samples may be enrolled in this studyafter considering specific circumstances and discussions with the Sponsor.
• Fresh tumor tissue samples (formalin-fixed, paraffin-embedded (FFPE) tumor blocksor FFPE sections) should be provided for retrospective detection of B7H3 expressionby the central laboratory using the immunohistochemistry [IHC] method; if freshtumor tissue samples are not available, FFPE tumor blocks previously archived areacceptable, 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 tothe 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 colonystimulating factor or granulocyte-macrophage colony stimulating factor within 14days prior to the first dose);
• Platelet count (PLT) ≥ 100×109/L (no platelet transfusion, thrombopoietin, orinterleukin-11 within 14 days prior to the first dose);
• Total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN) in the absence of obviousliver metastasis, or ≤ 3×ULN in the presence of liver metastasis;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN in theabsence 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 thecreatinine ≤ 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 thiscase, a stable anticoagulant regimen should be maintained with APTT and INRcontrolled 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 theinvestigational drug.
Expected survival ≥ 6 months.
Be capable of and willing to comply with the visits and procedures stipulated in thestudy protocol.
Exclusion
Exclusion Criteria:
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 aninterventional study.
Previously treated with topoisomerase I inhibitors or ADC therapy composed oftopoisomerase 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 organtransplantation.
Prior treatment with glucocorticoids for more than 28 consecutive days within 28days prior to the first dose of the investigational drug.
Patients received any live vaccine within 4 weeks prior to the first dose of theinvestigational drug, or plan to receive live vaccine during the study period.
Have pathological long bone fracture, or the risk of pathological long bonefracture.
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 priorto the first dose, or active gastric and duodenal ulcers, ulcerative colitis, orother gastrointestinal diseases that may cause hemorrhage or perforation in theopinion of the investigator.
Active serious infection (National Cancer Institute Common Terminology Criteria forAdverse 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 oraffect the response evaluation.
Unresolved toxicity of previous anti-tumor therapy.
History of severe hypersensitivity to inactive ingredients in the drug substance anddrug product or other monoclonal antibodies.
Have any diseases, medical conditions, organ system dysfunction, or socialconditions that may interfere with the subject ability to sign the ICF, adverselyaffect the subject ability to cooperate and participate in the study, or affect theinterpretation of study results, including but not limited to mental illness orsubstance/alcohol abuse, in the opinion of the investigator.
Study Design
Connect with a study center
Anhui Provincial Hospital
Hefei, Anhui
ChinaSite Not Available
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
ChinaSite Not Available
Peking University First Hospital
Peking, Beijing
ChinaSite Not Available
Peking University Third Hospital
Peking, Beijing
ChinaSite Not Available
Hunan Cancer Hospital
Hunan, Changsha
ChinaSite Not Available
Chongqing University Cancer Hospital
Chongqing, Chongqing
ChinaSite Not Available
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong 250117
ChinaSite Not Available
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 250117
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 250117
ChinaSite Not Available
Union Hospital of Huazhong University of Science and Technology Tongji Medical College
Wuhan, Hubei 250117
ChinaSite Not Available
Nanjing Drum Tower hospital
Nanjing, Jiangsu
ChinaSite Not Available
Nantong Tumor Hospital
Nantong, Jiangsu
ChinaSite Not Available
Liaoning Cancer Hospital
Shenyang, Liaoning 250117
ChinaSite Not Available
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning 250117
ChinaSite Not Available
Shandong Tumor Hospital
Jinan, Shandong 250117
ChinaSite Not Available
Zhongshan Hospital of Fudan University
Shanghai, Shanghai 250117
ChinaSite Not Available
Sichuan Provincial People's Hospital
Chengdu, Sichuan 250117
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, Sichuan 250117
ChinaSite Not Available
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin
ChinaSite Not Available
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang 250117
ChinaSite Not Available
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang 250117
ChinaSite Not Available
Ningbo Yinzhou No.2 Hospital
Ningbo, Zhejiang
ChinaActive - Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
ChinaSite Not Available
Fudan University Shanghai Cancer Center
Shanghai,
ChinaActive - Recruiting
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