A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC

Last updated: October 11, 2024
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

YL201 for Injection

Clinical Study ID

NCT06241846
YL201-CN-201-01
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects who understand relevant information of the study prior to initiation of thestudy 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 primaryhistological 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 thestudy 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 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);

  1. Patients with metastatic lesions confirmed by CT, MRI, or bone scan imaging within 28 days prior to the first dose.

  2. 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.

  1. Eastern cooperative oncology group performance status (ECOG PS) score of 0 or 1.

  2. 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.
  1. 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.

  2. Expected survival ≥ 6 months.

  3. Be capable of and willing to comply with the visits and procedures stipulated in thestudy protocol.

Exclusion

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 aninterventional study.

  3. Previously treated with topoisomerase I inhibitors or ADC therapy composed oftopoisomerase 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 organtransplantation.

  7. Prior treatment with glucocorticoids for more than 28 consecutive days within 28days prior to the first dose of the investigational drug.

  8. 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.

  9. Have pathological long bone fracture, or the risk of pathological long bonefracture.

  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 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.

  18. Active serious infection (National Cancer Institute Common Terminology Criteria forAdverse 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 oraffect the response evaluation.

  22. Unresolved toxicity of previous anti-tumor therapy.

  23. History of severe hypersensitivity to inactive ingredients in the drug substance anddrug product or other monoclonal antibodies.

  24. 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

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: YL201 for Injection
Phase: 2
Study Start date:
February 22, 2024
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui
    China

    Site Not Available

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Site Not Available

  • Peking University First Hospital

    Peking, Beijing
    China

    Site Not Available

  • Peking University Third Hospital

    Peking, Beijing
    China

    Site Not Available

  • Hunan Cancer Hospital

    Hunan, Changsha
    China

    Site Not Available

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong 250117
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 250117
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 250117
    China

    Site Not Available

  • Union Hospital of Huazhong University of Science and Technology Tongji Medical College

    Wuhan, Hubei 250117
    China

    Site Not Available

  • Nanjing Drum Tower hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • Nantong Tumor Hospital

    Nantong, Jiangsu
    China

    Site Not Available

  • Liaoning Cancer Hospital

    Shenyang, Liaoning 250117
    China

    Site Not Available

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning 250117
    China

    Site Not Available

  • Shandong Tumor Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 250117
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 250117
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 250117
    China

    Site Not Available

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin
    China

    Site Not Available

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 250117
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 250117
    China

    Site Not Available

  • Ningbo Yinzhou No.2 Hospital

    Ningbo, Zhejiang
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai,
    China

    Active - Recruiting

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