A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors

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.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Active autoimmune disease caused by prior anticancer treatment, unless currently controlled by replacement therapy only. * Any kind of leukemia * Previously received an organ transplant (other than corneal transplants) or hematopoietic stem cell transplantation * Known active central nervous system metastases and/or carcinomatous meningitis * Cerebral vascular event within 6 months before Screening * Unstable cardiopulmonary status defined by uncontrolled congestive heart failure of New York Heart Association Grade III or IV, unstable angina, or myocardial infarction within 6 months before Screening * High grade ocular disease such as uncontrolled glaucoma