BridgeMD
New treatment option for Advanced Prostate Cancer
Official title A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
ClinicalTrials.gov ID: NCT07198633
What this study is testing
What is QLC5508?
QLC5508 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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 people 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, people 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 people who have undergone bilateral orchiectomy).
- Sufficient blood samples must be provided during the screening period for genetic mutation testing.
- 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 people receiving QLC5508, history of non-infectious interstitial lung disease (ILD) or pneumonitis.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.