Tests QLC5508 and QLH12016 with other therapies in advanced prostate cancer
Tests QLC5508 and QLH12016 combined with abiraterone or enzalutamide in advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 1/2
Where in China
- Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Pharmaceutical Co., Ltd.
- Trial code
- NCT07198633
- Record updated
- 2 June 2026
- Original description
This study is an open-label, multicenter Phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 in combination with NHA (abiraterone or enzalutamide), QLC5508 in combination with QLH12016, QLC5508 in combination with QLH12016 and NHA (abiraterone or enzalutamide), and QLH12016 in combination with NHA (abiraterone or enzalutamide) in subjects with advanced prostate cancer.Read full original descriptionShow less
An 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
This study is an open-label, multicenter Phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 in combination with NHA (abiraterone or enzalutamide), QLC5508 in combination with QLH12016, QLC5508 in combination with QLH12016 and NHA (abiraterone or enzalutamide), and QLH12016 in combination with NHA (abiraterone or enzalutamide) in subjects with advanced prostate cancer.
The study consists of two stages:
Phase Ib: is the combination dose-escalation stage, during which the recommended Phase II dose (RP2D) will be determined.
Phase II is the efficacy exploration stage, in which, based on the RP2D established in Phase Ib, the therapeutic efficacy will be further evaluated in the target indication.
Inclusion: 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; Histologically or cytologically confirmed adenocarcinoma of the prostate; Radiologically confirmed metastatic prostate cancer; For subjects with mCRPC, serum testosterone must be at castrate levels, and they must have demonstrated either PSA progression or radiographic progression; Must have undergone surgical castration or be willing to receive medical castration; For Phase Ib, subjects must have experienced failure, intolerance, or refusal of standard therapy; 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); Sufficient blood samples must be provided during the screening period for genetic mutation testing.
Exclusion: 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; Presence of factors that may affect drug administration, intake, or absorption; History of epilepsy, or a condition that could provoke seizures within 12 months prior to the first administration of the investigational medicinal product; Known history of substance abuse, alcoholism, or drug addiction; or prior history of significant neurological or psychiatric disorders, including dementia or hepatic encephalopathy; Clinically uncontrolled third-space fluid accumulation prior to the first administration of the investigational medicinal product; For subjects receiving QLC5508, history of non-infectious interstitial lung disease (ILD) or pneumonitis; Presence of severe cardiovascular or cerebrovascular disease; Active, uncontrolled infection; History of other malignancies within 5 years prior to the first administration of the investigational medicinal product; Presence of moderate to severe pulmonary disease that significantly impairs lung function.