Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, and clinical activity of OBI-3424 in patients with advanced or metastatic solid tumors.

"Competing interests Dr. AMT has received clinical trial research funding (through her institution) from OBI Pharma USA Inc., IMMATICS, Parker Institute for Cancer Immunotherapy, Agenus, Tempus, Tvardi, Boston Biomedical, and Karus Therapeutics. Dr. AMT has served in a consulting or advisory role for Vincerx, Diaccurate, and BrYet. Dr. CFV has no conflicts of interest to report. Dr. RW has no conflicts of interest to report. Dr. C-SS is an employee of OBI Pharma Inc. Dr. PH was an employee of OBI Pharma Inc. at the time the study was conducted. Dr. TEP was an employee of OBI Pharma USA Inc. at the time the study was conducted."

"Funding This study was funded by OBI Pharma Inc., Taipei City, Taiwan."

"The study was conducted at two centers in the United States: The University of Texas MD Anderson Cancer Center and The Ohio State University Comprehensive Cancer Center. All patients provided written informed consent at the time of enrollment stating that they were aware of the investigational nature of the study. The study was approved by the institutional review boards of both institutions and conducted in accordance with the ethical principles of the International Council for Harmonization Guideline for Good Clinical Practice, the Declaration of Helsinki, and applicable local regulations. The study was registered at www.clinicaltrials.gov (NCT03592264; July 19, 2018). Ethics approval and consent to participate: All patients provided written informed consent at the time of enrollment stating that they were aware of the investigational nature of the study. The study was approved by the institutional review board of both institutions and conducted in accordance with the ethical principles of the International Council for Harmonization Guideline for Good Clinical Practice, the Declaration of Helsinki, and applicable local regulations. The study was registered at www.clinicaltrials.gov (NCT03592264; July 19, 2018)."