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Brief Title: A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors
Official Title: A Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART4215 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors
Study ID: NCT04991480
Brief Summary: This clinical trial is evaluating a drug called ART4215 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART4215 that can be given safely to participants alone and in combination with talazoparib * Learn more about the side effects of ART4215 alone and in combination with talazoparib * Learn more about the effectiveness of ART4215 alone and in combination with talazoparib * Learn more about the effectiveness of ART4215 alone and in combination with niraparib
Detailed Description: This is an open-label Phase I/IIa study designed to evaluate ART4215, a new first-in-class investigational medicinal product that is a potent and selective inhibitor of deoxyribonucleic acid (DNA) polymerase (pol) theta. ART4215 is being developed as an oral anti-cancer agent for monotherapy treatment of patients with cancers that harbor defects in DNA repair and in combination with anticancer medicines that cause DNA damage.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Yale School of Medicine, New Haven, Connecticut, United States
Florida Cancer Specialists, Orlando, Florida, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Oklahoma University, Oklahoma City, Oklahoma, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Tennessee Oncology, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Sarah Cannon Research Institute, London, England, United Kingdom
Name: Erika Hamilton, MD
Affiliation: Tennessee Oncology
Role: STUDY_CHAIR
Name: Timothy Yap, MBBS, PhD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR