The purpose of this trial is to find the maximum tolerated and recommended Phase 2 dose of KUP-101A and to evaluate its safety and tolerability. Additionally, pharmacokinetics and pharmacodynamics will be assessed, and first data on KUP-101A's efficacy in patients with advanced solid tumors will be obtained.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Intravenous infusion of KUP-101A
Klinikum der Ludwig-Maximilians-Universität München, Klinik und Poliklinik für Dermatologie und Allergologie
Munich, Bavaria, Germany
RECRUITINGUniversitätsklinikum Würzburg
Würzburg, Bavaria, Germany
RECRUITINGFachklinik Hornheide
Münster, North Rhine-Westphalia, Germany
RECRUITINGProportion of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and related TEAEs
Time frame: From enrollment until three months after last dose administration
Proportion of patients with dose-limiting toxicities (DLTs)
Time frame: From start of treatment until one week after last dose administration.
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Time frame: From enrollment until three months after last dose administration
Incidence of abnormal clinical findings in 12-lead ECG parameters and vital signs
Time frame: From enrollment until three months after last dose administration
Area Under the Concentration time Curve from Time 0 Extrapolated to Infinity
Time frame: up to 3 weeks
Maximum Observed Concentration
Time frame: up to 3 weeks
Time of the maximum observed concentration
Time frame: up to 3 weeks
Apparent terminal elimination half-life
Time frame: up to 3 weeks
Change from baseline in cytokine levels
Time frame: From enrollment until three months after last dose administration
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