QLF4113 in Participants With Metastatic Prostate Cancer

This is an open-label, dose-escalation and expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLF4113 monotherapy in participants with metastatic prostate cancer. The Phase I trial consists of two parts: Phase Ia and Phase Ib. Phase Ia is a dose-escalation study of QLF4113 monotherapy to determine the recommended phase two dose and assess safety and PK. Then the study will proceed to Phase Ib, a dose-expansion study to further evaluate the preliminary efficacy and safety of QLF4113 monotherapy under the selected doses.

Inclusion Criteria: * Participants voluntarily agree to participate and sign the informed consent form. * Male, aged ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. * Life expectancy ≥ 3 months. * Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine carcinoma or small cell carcinoma features. * Confirmed metastatic Castration-Resistant Prostate Cancer (mCRPC). * Failed or are intolerant to standard therapies * Adequate function of major organs as defined by the protocol. * Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy). * Prior to the first use of the investigational drug, recovery from all reversible adverse events (AEs) related to prior anticancer treatments Exclusion Criteria: * Previously treated with drugs targeting CD3 or CD2. * Significant Cardiovascular Diseases * Active, Uncontrolled Infections * Immunosuppressive Treatment before the first dose of the investigational drug * Clinically Uncontrolled Third-Space Fluid Accumulation * History of Other Malignancies within 5 years prior to the first dose of the investigational drug * Moderate to Severe Pulmonary Diseases significantly affecting lung function, * Current Hepatic Encephalopathy, Hepatorenal Syndrome, or Cirrhosis classified as Child-Pugh B or worse. * Allergy to the Investigational Drug or its Components. * Any Condition deemed by the investigator to increase study-related risks, interfere with the interpretation of study results, or otherwise render the participant unsuitable for inclusion.