Qilu Pharma Initiates Phase Ib/II Clinical Trial of QLH12016 Capsule in Combination with Novel Hormonal Therapy for Advanced Prostate Cancer

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Qilu Pharmaceutical Co., Ltd.'s open-label, multi-center Phase Ib/II clinical study on the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLH12016 in combination with novel endocrine therapy in subjects with advanced prostate cancer has been initiated. The clinical trial registration number is CTR20253297, and the initial information disclosure date was August 18, 2025.

The drug is in capsule form, available in 25mg and 100mg specifications, administered orally once a day. The combined abiraterone acetate is in tablet form, with a specification of 250mg per tablet, administered orally at 1000mg once a day. The main purpose of this trial is to evaluate the safety and tolerability of QLH12016 in combination with novel endocrine therapy in subjects with advanced prostate cancer, and to determine the recommended dose for Phase II trials; to assess the prostate-specific antigen 50 response rate and objective response rate in subjects with advanced prostate cancer.

QLH12016 Capsule is a chemical drug indicated for advanced prostate cancer. Advanced prostate cancer refers to the condition where cancer cells have spread beyond the prostate, with symptoms possibly including difficulty urinating, hematuria, and bone pain. Diagnosis relies on prostate-specific antigen testing, imaging examinations, etc., and treatment options include endocrine therapy, chemotherapy, etc.

The primary endpoint indicators of this trial include: In Phase Ib, evaluating the safety and tolerability of QLH12016 in combination with novel endocrine therapy in subjects with advanced prostate cancer, and determining the recommended dose for Phase II trials; In Phase II, assessing the prostate-specific antigen 50 response rate and objective response rate of QLH12016 in combination with novel endocrine therapy in subjects with advanced prostate cancer. Secondary endpoint indicators include: In Phase Ib, evaluating the pharmacokinetic characteristics and preliminary efficacy of QLH12016 in combination with novel endocrine therapy in subjects with advanced prostate cancer; In Phase II, assessing other efficacy endpoints and safety of QLH12016 in combination with novel endocrine therapy in subjects with advanced prostate cancer.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 62 participants.

Risk Warning: The market has risks, and investment should be made with caution. This article is automatically published by an AI large model based on a third-party database. Any information appearing in this article (including but not limited to individual stocks, comments, forecasts, charts, indicators, theories, or any form of expression, etc.) is only for reference and does not constitute personal investment advice. Due to issues such as the quality of the third-party database, we are unable to verify or confirm the authenticity and completeness of the data. Therefore, the content of this article may contain inaccuracies, incompleteness, or misleading information. Please refer to the company's official announcements for specific details. If you have any questions, please contact biz@staff.sina.com.cn.

Editor: Xiaolang Express