Status:
NOT_YET_RECRUITING
A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Advanced Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Eligibility Criteria
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.
- Presence of severe cardiovascular or cerebrovascular disease.
- Active, uncontrolled infection.
- Clinically uncontrolled third-space fluid accumulation prior to the first administration of the investigational medicinal product.
- 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.
- For subjects receiving QLC5508, history of non-infectious interstitial lung disease (ILD) or pneumonitis.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT07198633
Start Date
October 1 2025
End Date
December 1 2027
Last Update
September 30 2025
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