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).
Participants must voluntarily sign the Informed Consent Form (ICF) and demonstrate the capacity to understand and adhere to study requirements.
Participants must be ≥18 years of age at the time of signing the ICF, regardless of sex.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 (refer to Appendix 2).
Life expectancy of ≥6 months.
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;
Presence of uncontrolled or symptomatic Central Nervous System (CNS) metastases, leptomeningeal metastases, or spinal cord compression due to metastasis prior to signing the ICF. The following exception applies: Participants with symptomatic CNS metastases who received treatment and have achieved radiological stability for ≥4 weeks (defined as two brain images acquired using the same imaging modality, both collected after CNS metastasis treatment and at least 4 weeks apart, showing no evidence of intracranial progression upon comparison), exhibit no signs of cerebral edema, and have discontinued systemic corticosteroid treatment (at any dose) for >2 weeks prior to the first dose of the investigational product;
Parallel
QLC5508 (Investigational Product / Formulation T)
DrugSingle intravenous (IV) infusion of QLC5508 for pharmacokinetic (PK) and C-QTc assessment in patients with advanced solid tumors.
QLC5508 (Reference Product / Formulation R)
DrugSingle IV infusion of QLC5508 for comparative PK evaluation against the investigational formulation.
Itraconazole
DrugMultiple oral doses of itraconazole capsules to evaluate the drug-drug interaction (DDI) potential via CYP3A4 inhibition.
Darolutamide
DrugMultiple oral doses of darolutamide tablets to evaluate the drug-drug interaction (DDI) potential.
Rifampicin
DrugSingle oral dose of rifampicin capsules to evaluate the DDI potential.
The correlation between the plasma concentration of the QLC5508 payload and the change from baseline in the QTc interval (ΔQTc) derived from the concentration-QTc (C-QTc) model.
Following a single intravenous injection of QLC5508 Formulation T (investigational product) versus Formulation R (reference product), the Cmax of QLC5508
TheAUC0-t of QLC5508 following single use or co-administration with itraconazole
The AUC0-∞ of QLC5508 following single use or co-administration with darolutamide
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