QLC5508 in Advanced Solid Tumors:: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interac… (NCT07620041) | Clinical Trial Compass
Not Yet RecruitingPhase 1
QLC5508 in Advanced Solid Tumors:: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction
China48 participantsStarted 2026-06-05
Plain-language summary
A clinical trial of QLC5508 for advanced solid tumors
The goal of this clinical trial is to learn if QLC5508 can be given safely to adults with advanced solid tumors. It will also learn how two different formulations of QLC5508 compare in the body, and whether other drugs affect QLC5508. The main questions it aims to answer are:
Does a single injection of QLC5508 change the heart's electrical activity (QTc interval)?
How do the test formulation and the reference formulation of QLC5508 compare in the body (pharmacokinetics)?
Do other drugs (itraconazole, darolutamide, or rifampicin) change how the body processes QLC5508?
Investigators will compare the test formulation to the reference formulation, and will also give QLC5508 together with itraconazole, darolutamide, or rifampicin to look for drug-drug interactions.
Participants will:
Receive QLC5508 by injection into a vein;
Join one of three groups: two groups will receive both formulations of QLC5508 at different times (crossover) and also take rifampicin or itraconazole; the third group will take darolutamide with QLC5508;
Have heart monitoring (Holter) during the first dose;
Undergo regular blood tests, safety checks, and immunogenicity testing (to see if the body develops antibodies against QLC5508).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Renal function: Serum creatinine ≤1.5 × Upper Limit of Normal (ULN); for participants with creatinine \>1.5 × ULN, Creatinine Clearance (CrCl) calculated via the Cockcroft-Gault formula must be ≥60 mL/min.
. Hepatic function: Total bilirubin ≤1.5 × ULN (≤3 × ULN permitted for participants with Gilbert's syndrome; ≤2.5 × ULN permitted for those with liver metastases). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN permitted for participants with Gilbert's syndrome or liver metastases). Albumin (ALB) ≥25 g/L.
. Coagulation: International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Following a single intravenous injection of QLC5508 Formulation T (investigational product) versus Formulation R (reference product), the Cmax of QLC5508
Timeframe: From baseline to approximately Month 6
2
TheAUC0-t of QLC5508 following single use or co-administration with itraconazole
Timeframe: From baseline to approximately Month 6
3
The AUC0-∞ of QLC5508 following single use or co-administration with darolutamide
Timeframe: From baseline to approximately Month 6
4
The Tmax of QLC5508 following single use or co-administration with rifampicin
. Includes oral fluoropyrimidines, small molecule targeted drugs, endocrine therapy, palliative radiotherapy, or traditional Chinese medicine (TCM) treatments with anti-tumor indications within 2 weeks prior to the first dose;
. Includes mitomycin or nitrosourea-based drugs within 6 weeks prior to the first dose;
. Includes cell-based therapies or anti-tumor vaccines within 8 weeks prior to the first dose;