Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms

This is a Phase I/II, open-label, non-randomized, multicenter study of KLS-1 administered via intravenous (IV) infusions in 21-day treatment cycles to adult participants with different types of solid tumors and CLL. Phase I (a dose-escalation part) will explore multiple-dose levels, PK and select a single dose level to explore in Phase II of the study. A conventional 3+3 design will be utilized. Once a dose level is selected, the additional cohort of 3-6 patients will be enrolled to assess more effectively the safety during 2 treatment cycles and confirm Phase II dose (P2D). Phase II (a dose expansion part) will evaluate the evidence of anti-tumor activity of the selected dose in four dose expansion cohorts of patients with different types of solid locally advanced and/or metastatic tumors or CLL. The study is designed to identify and characterize the safety, tolerability, efficacy, and PK profile of KLS-1 in oncological patients.