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Clinical Trial Summary

This phase I trial tests the safety, side effects, and best dose of a new intervention, AU409, in treating patients with primary liver cancers that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or advanced solid tumors that have spread to the liver (liver metastatic disease). AU409 may stop cancer from growing and spreading. This trial may help researchers determine if AU409 is safe and effective in treating patients with liver cancers and solid tumors with liver metastatic disease.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine maximum tolerated dose (MTD) of RNA transcription modulator AU-409 (AU409) and the recommended phase II dose (RP2D). II. To characterize the safety and tolerability of AU409 by assessing toxicities per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 criteria. SECONDARY OBJECTIVES: I. To obtain a preliminary assessment of anti-tumor activity of AU409 via objective radiologic response using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. II. To determine pharmacokinetics of AU409 in patients with advanced-stage solid tumors. EXPLORATORY OBJECTIVES: I. To evaluate the concentration of AU409 in tumor tissue from liver biopsy samples obtained from a subset of patients treated with AU409 at dose level 4 (300 mg) and above. II. To evaluate expression of genes with TATA box promotion regions on pre- and post- treatment liver biopsy samples. OUTLINE: This is a dose-escalation study. Patients receive AU409 orally (PO) on study. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05791448
Study type Interventional
Source University of Southern California
Contact Xiomara Menendez, RN
Phone 323-865-0212
Email Xiomara.Menendez@med.usc.edu
Status Recruiting
Phase Phase 1
Start date March 29, 2023
Completion date March 29, 2027

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