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

Recruiting
18 years of age
Male
Phase 2

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Overview

This is a multicenter, open-label, Phase 2 study. The study will enroll subjects with metastatic castration-resistant prostate cancer (mCRPC) previously treated with at least 1 prior line of novel hormone therapy (NHT). NHT includes abiraterone, enzalutamide, apalutamide, darotamide, or rezvilutamide. Subjects must have received no more than 2 prior lines of taxane-containing regimen.

This study consists of two parts. Part 1 will preliminarily assess the efficacy and tolerability of YL201 at 2.0, 2.4, or 2.8 mg/kg with approximately 40 subjects. Part 2 will further assess the efficacy and safety of YL201 at the recommended expansion dose (RED) obtained from Part 1 with up to 60 subjects.

YL201 will be administered intravenously (IV) on Day 1 of each 3-week cycle until criteria of treatment discontinuation are met. Subjects will undergo regular testing for signs of disease progression (PD) using computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, and prostate-specific antigen (PSA) blood test. Routine examinations and blood tests will be performed and evaluated by the study physician.

Eligibility

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 who are histologically or cytologically confirmed prostate cancer.
  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.
  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.
  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.

Study details

Metastatic Castration-resistant Prostate Cancer (mCRPC)

NCT06241846

MediLink Therapeutics (Suzhou) Co., Ltd.

18 May 2024

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