Actively Recruiting
An Open-label, Multicenter Phase Ib/II Study Evaluating QLC5508 and/or QLH12016 Combined With Other Anti-tumor Therapies in Advanced Prostate Cancer
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-06-02
212
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor effects of QLC5508 and QLH12016 combined with other anti-tumor therapies in men with advanced prostate cancer. This open-label, multicenter Phase Ib/II trial aims to find the best dose and explore how well these combinations work, especially in patients with metastatic disease and castrate-resistant prostate cancer. The study has two stages: Phase Ib involves carefully increasing doses of these drugs to determine the recommended Phase II dose, while Phase II focuses on assessing their therapeutic effects at that dose. Participants may receive QLC5508 by injection, and oral medications including abiraterone, enzalutamide, and QLH12016 in various combinations as specified in the protocol. Participants will be evaluated throughout the study with blood tests for genetic mutation analysis, monitoring for side effects, and assessments of prostate-specific antigen (PSA) response and tumor response over about one year. Safety, tolerability, and pharmacokinetics will be closely observed during Phase Ib, while Phase II will measure effectiveness through PSA50 response and objective response rate. The study is expected to continue until late 2027.
CONDITIONS
Brief Title
A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, aged 18 years or older
- Voluntary agreement to participate with signed informed consent
- ECOG performance status score of 0-1
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed prostate adenocarcinoma
- Radiologically confirmed metastatic prostate cancer
- For metastatic castrate-resistant prostate cancer (mCRPC), serum testosterone at castrate levels and evidence of PSA or radiographic progression
- Surgical castration or willingness for medical castration
- For Phase Ib, prior failure, intolerance, or refusal of standard therapy
- Adequate organ function as defined by the protocol
- Agreement to use effective contraception during the study (except those with bilateral orchiectomy)
- Ability to provide sufficient blood samples for genetic mutation testing during screening
You will not qualify if you...
- Prior treatment with AR PROTAC, abiraterone, enzalutamide, or B7H3-targeted therapies
- Central nervous system metastases, leptomeningeal metastases, or spinal cord compression requiring hormonal therapy
- Extensive radiotherapy within 4 weeks before first dose of study drug
- Treatment with other investigational drugs or major surgery within 4 weeks before first dose
- Factors affecting drug administration, intake, or absorption
- History of epilepsy or seizure-provoking conditions within 12 months before first dose
- Known substance abuse, alcoholism, significant neurological or psychiatric disorders including dementia or hepatic encephalopathy
- Severe cardiovascular or cerebrovascular disease
- Active uncontrolled infection
- Clinically uncontrolled third-space fluid accumulation before first dose
- History of other cancers within 5 years before first dose
- Moderate to severe pulmonary disease impairing lung function
- For QLC5508 recipients, history of non-infectious interstitial lung disease or pneumonitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days after the first dose
Participants receive initial dosing to establish maximum tolerated dose and recommended phase II dose.
Multiple visits during first 28 days
Duration - Up to approximately 1 year or until confirmed progressive disease
Participants receive QLC5508 and/or QLH12016 combined with other anti-tumor therapies as specified in the protocol.
Regular visits for treatment and assessment during treatment period
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
X
Xin Yao, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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