Qilu Pharmaceutical Initiates Phase II Clinical Trial of QLC5508 for Advanced Prostate Cancer

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Qilu Pharmaceutical Co., Ltd. has initiated an open, multi-center Phase Ib/II clinical study on the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 and/or QLH12016 in combination with other anti-tumor treatments in subjects with advanced prostate cancer. The clinical trial registration number is CTR20253721, and the initial information disclosure date was September 17, 2025.

There are two investigational drugs in this trial: QLC5508 for injection, a freeze-dried powder injection with a specification of 50mg, administered intravenously at a dose of 2.0 mg/kg every two weeks; and QLH12016 capsules, with a specification of 25mg, administered orally at a dose of 600 mg once daily. The purpose of this trial is to evaluate the safety and tolerability of QLC5508 in combination with novel endocrine therapy in subjects with advanced prostate cancer and to determine the recommended dose for Phase II trials.

QLC5508 for Injection is a biological product indicated for advanced prostate cancer. Advanced prostate cancer refers to the condition where cancer cells have spread to tissues or organs beyond the prostate, with symptoms possibly including difficulty urinating, hematuria, and bone pain. Diagnosis relies on prostate-specific antigen (PSA) testing, imaging examinations, etc.

The primary endpoint indicators of this trial include: Phase Ib evaluation of QLC5508 combined with novel endocrine therapy; incidence and severity of adverse events; Phase II assessment of the prostate-specific antigen 50 (PSA50) response rate and objective response rate of QLC5508 combined with various treatment regimens in subjects with advanced prostate cancer. Secondary endpoint indicators include: Phase Ib drug concentration after single and multiple doses of QLC5508 when combined with NHA, preliminary efficacy; Phase II evaluation of other efficacy endpoints and safety of various combination therapies.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 200 participants.

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Editor: Xiaolang Express