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Brief Title: A First-in-Humans Dose Finding Study for an Aryl Hydrocarbon Receptor Inhibitor (AhRi) in Patients With Advanced Cancer
Official Title: An Open-label, Phase 1, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Tumor Response Profile of the Aryl Hydrocarbon Receptor Inhibitor (AhRi) BAY 2416964 in Participants With Advanced Solid Tumors
Study ID: NCT04069026
Brief Summary: In this study researchers want to gather relevant information regarding the safety of BAY2416964 and how well the drug works in participants with a type of solid tumors that cannot be cured by currently available drugs. Researchers want to find the highest dose of BAY2416964 that participants could take without having too many side effects, how the drug is tolerated and the way the body absorbs, distributes and gets rid of the study dug. BAY2416964 is a small molecule which blocks the Aryl Hydrocarbon Receptor (a protein involved in immune cell reaction to tumor cells) allowing the body to use its immune response against the tumor cells.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Yale University School of Medicine, New Haven, Connecticut, United States
Greenville Health System, Greenville, South Carolina, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
South Texas Accelerated Research Therapeutics | START San Antonio, San Antonio, Texas, United States
Princess Margaret Hospital-University Health Network, Toronto, Ontario, Canada
CHU de Québec-Hôpital de l'Enfant-Jésus, Quebec, , Canada
Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, Sachsen, Germany
Charité Campus Benjamin Franklin (CBF), Berlin, , Germany
Institut Català d'Oncologia Hospitalet, Hospitalet de Llobregat, Barcelona, Spain
Hospital Ramón y Cajal | Oncología, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Virgen de la Victoria | Cardiology Department, Málaga, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Royal Marsden NHS Trust (Surrey), Sutton, Surrey, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Christie Hospital, Manchester, , United Kingdom