Metastatic Malignant Solid Neoplasm Clinical Trial
Official title:
A Phase I Trial of the P97 Inhibitor CB-5339 in Patients With Advanced Solid Tumors and Lymphomas
This phase I trial studies the side effects and best dose of CB-5339 in treating patients with solid tumors that has spread to other places in the body (advanced) or lymphomas. CB-5339 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVE: I. To establish the safety, tolerability, and recommended phase 2 dose (RP2D) of p97 inhibitor CB-5339 tosylate (CB-5339) administered orally on a schedule of once daily, 4 days on and 3 days off, in patients with advanced solid tumors and lymphomas. SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetic profiles of CB-5339. II. To assess the preliminary antitumor activity of CB-5339 in patients with advanced solid tumors and lymphomas. III. To determine the effects of CB-5339 on the ubiquitin proteasome system and on markers of cell death in pre- and post-treatment tumor biopsies and peripheral blood mononuclear cell (PBMC)s. EXPLORATORY OBJECTIVE: I. To evaluate potential associations between CB-5339 activity and genomic alterations assessed in circulating tumor deoxyribonucleic acid (DNA) (ctDNA). OUTLINE: This is a dose-escalation study. Patients receive p97 inhibitor CB-5339 tosylate orally (PO) once daily (QD) 4 days on and 3 days off. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days. ;
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