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.
Histologically confirmed cancer with evidence of advanced disease for which no other standard treatment is available
ECOG Performance status of 0 to 2
Adequate hematological, renal, and hepatic organ function
Previous systemic treatment with TLR agonists, with the exception of TLR agonists used as vaccine adjuvants.
Known additional malignancy that is progressing or requires active treatment
Diagnosis of immunodeficiency
Active autoimmune disease not caused by prior anticancer treatment that required systemic immunosuppressive treatment in the past 2 years
Sequential
KUP-101A
DrugIntravenous infusion of KUP-101A
7
Treatment groupsSee each treatment group below.
Proportion of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and related TEAEs
Proportion of patients with dose-limiting toxicities (DLTs)
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Incidence of abnormal clinical findings in 12-lead ECG parameters and vital signs
Area Under the Concentration time Curve from Time 0 Extrapolated to Infinity
Maximum Observed Concentration
Time of the maximum observed concentration
Apparent terminal elimination half-life
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