Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms

The goal of this clinical trial is to test the safety and preliminary efficacy of a new drug, KLS-1, in adults with different types of solid tumors and chronic lymphocytic leukemia (CLL). The main questions it aims to answer are: * To define Dose Limiting Toxicities (DLT) and maximum tolerated dose (MTD) of KLS-1 * To select the recommended Phase II Dose (P2D) of KLS-1 * To determine the single dose and multiple dose PK profile following IV administration of KLS-1 * What is the safest and most effective dose of KLS-1? * Does KLS-1 show anti-tumor activity in patients? * To evaluate preliminary efficacy of KLS-1 in up to 4 cohorts of locally advanced or metastatic solid tumor (malignant melanoma, prostate cancer, pancreatic cancer), or CLL. * To evaluate 12-months progression-free survival (PFS) and duration of response (DOR) follow-up after the last dose of KLS-1 Participants will: * Receive KLS-1 through intravenous (IV) infusions in 21-day cycles. * Be monitored for side effects and improvements in their malignancy. Investigators will compare different doses of KLS-1 in the initial phase to find the best dose for Phase II. Once the P2D is defined, it will be tested in a larger group to see its effects on locally advanced or metastatic solid tumor (malignant melanoma, prostate cancer, pancreatic cancer) and CLL.

This description comes directly from the study's public registry record.

Max Temnik  ·  +1 305 331-12 13  ·  clinicaltrials@vectorvitale.com

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