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QLC5508 and QLH12016 for Advanced Prostate Cancer

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What is being tested

QLC5508

+ abiraterone acetate

+ enzalutamide

Drug
Who is being recruted

Over 18 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorQilu Pharmaceutical Co., Ltd.
Study ContactXin Yao, PHD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on finding the best ways to use new drug combinations to treat advanced prostate cancer. It involves testing the safety and effectiveness of a drug called QLC5508, both on its own and combined with other treatments such as abiraterone, enzalutamide, and another drug called QLH12016. The goal is to determine how well these combinations might work to fight prostate cancer and to see if they cause any side effects. The study is conducted across multiple centers and is open to participants with advanced stages of prostate cancer. Finding effective combinations is crucial because it could lead to better treatment options for those with this challenging condition. Participants in the study will receive different combinations of the drugs, either through oral intake or injections, depending on the specific trial setup. The study is organized into two parts: the first part, Phase Ib, focuses on adjusting the doses to determine the safest and most effective dosage. The second part, Phase II, looks closely at how well the chosen dosages work in treating prostate cancer. Researchers will monitor participants for any side effects and measure the tumor's response to the treatment to assess its benefits. The study aims to gather important information on the potential of these drug combinations in improving the management of advanced prostate cancer.

Official TitleAn Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
NCT07198633
Principal SponsorQilu Pharmaceutical Co., Ltd.
Study ContactXin Yao, PHD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

212 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

12 inclusion criteria required to participate
The subject voluntarily agrees to participate and has signed the informed consent form.
Male, aged ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Life expectancy of at least 3 months.
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13 exclusion criteria prevent from participating
Prior treatment with the following agents: AR PROTAC, abiraterone, enzalutamide, or B7H3-targeted therapies.
Presence of central nervous system (CNS) metastases, leptomeningeal metastases, or spinal cord compression requiring hormonal therapy.
Receipt of extensive radiotherapy within 4 weeks prior to the first administration of the investigational medicinal product.
Treatment with other investigational drugs or major surgery within 4 weeks prior to the first administration of the investigational medicinal product.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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Recruiting soonNo study centers