NCT07198633 A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
| NCT ID | NCT07198633 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Advanced Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 212 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 212 participants in total. It began in 2025-11-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07198633 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Advanced Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07198633 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07198633 currently recruiting?
Yes, NCT07198633 is actively recruiting participants. Contact the research team at yaoxin@tjmuch.com for enrollment information.
Where is the NCT07198633 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07198633 clinical trial?
NCT07198633 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 212 participants.
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