This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLS2401 as monotherapy in patients with advanced prostate cancer.
The Phase I trial is divided into Phase Ia and Phase Ib components. The Phase Ia component involves a dose-escalation study of QLS2401 as monotherapy; should the results from the Phase Ia study meet the predefined criteria, a Phase Ib efficacy-expansion study of QLS2401 as monotherapy will be conducted.
Study participants enrolled voluntarily and signed an informed consent form. Male participants aged ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Expected survival time of at least 3 months.
Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine or small cell carcinoma features.
Presence of central nervous system (CNS) metastases, leptomeningeal metastases, or metastatic spinal cord compression requiring hormonal therapy (at doses exceeding the physiological substitution dose) prior to the first administration of the investigational drug;
Receipt of radiotherapy involving irradiation of more than 25% of the bone marrow within 4 weeks prior to the first administration of the investigational drug; or receipt of localized radiotherapy (excluding cranial radiotherapy) within 2 weeks prior to the first administration of the investigational drug;
Receipt of treatment with other investigational drugs or major surgery within 4 weeks prior to the first administration of the investigational drug (sufficient wound healing following major surgery must be clinically assessed); or planned bilateral orchiectomy during the study treatment period;
History of epilepsy or occurrence of any condition that could trigger epileptic seizures within 12 months prior to the first administration of the investigational drug;
Single group
QLS2401
DrugParticipants will receive QLS2401 via intravenous (IV) or subcutaneous injection
Maximum tolerated dose (MTD) (Phase Ia)
MTD is determined based on the incidence of protocol-defined DLT during the first treatment cycle. Using the 3+3 dose-escalation design, MTD is defined as the highest dose level at which fewer than a predefined proportion of subjects experience DLT, while the next higher dose level exceeds the DLT threshold
Maximum administered dose (MAD)(Phase Ia)
MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.
Recommended phase II dose (RP2D) (Phase Ia)
The RP2D will be comprehensively evaluated based on the safety, PK characteristics, and efficacy data from the Phase Ib study.
The incidence and severity of adverse events (AE) (Phase Ia)
Incidence and severity of adverse events (AEs) evaluated according to the NCI-CTCAE v5.0
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