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Brief Title: A Study of HFB301001 in Adult Patients With Advanced Solid Tumors
Official Title: A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients With Advanced Solid Tumors
Study ID: NCT05229601
Brief Summary: The purpose of this study is to test the safety and tolerability of HFB301001 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable doses of HFB301001 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer they have.
Detailed Description: This is a Phase I, first-in-human, open-label, dose escalation and expansion study in adult patients with advanced cancers. The study will comprise of: 1. A Screening Period of up to 28 days 2. A Treatment Period during which participants will receive the study drug on the first day of each cycle where each cycle is 28 days. Number of cycles depends on how the disease responds to the study drug 3. A Follow-Up Period which involves 1 visit
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic, Scottsdale, Arizona, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Mayo Clinic, Jacksonville, Florida, United States
University of Maryland, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
NEXT Virginia Cancer Specialists, Fairfax, Virginia, United States
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain