Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT07198633
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07198633
Study Brief:
Protocol Section:
NCT07198633