Spots Global Cancer Trial Database for A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of RO7227166 in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of RO7227166 in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Official Title: An Open-Label, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Antitumor Activity of RO7227166 (a CD19 Targeted 4-1BB Ligand) in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Study ID: NCT04077723
Conditions
Study Description
Brief Summary: This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of RO7227166 in participants with relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL). RO7227166 will be administered by intravenous (IV) infusion in combination with obinutuzumab and in combination with glofitamab. A fixed dose of obinutuzumab (Gpt; pre-treatment) will be administered seven days prior to the first administration of RO7227166 and seven days prior to the first administration of glofitamab. This entry-into-human study is divided into a dose-escalation stage (Part I and Part II) and a dose expansion stage (Part III).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Medical Center; Hematology, Pasadena, California, United States
University of California San Francisco, San Francisco, California, United States
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center, Denver, Colorado, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Peter Maccallum Cancer Centre, Melbourne, Victoria, Australia
UZ Gent, Gent, , Belgium
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, København Ø, , Denmark
CHRU de Lille, Lille, , France
CHU Montpellier - Saint ELOI, Montpellier, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
CHU DE RENNES - CHU Pontchaillou; Service d'Hématologie Clinique Adulte, Rennes, , France
ASST PAPA GIOVANNI XXIII; Ematologia, Bergamo, Lombardia, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano, Lombardia, Italy
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, , Spain
The HOPE Clinical Trials Unit, Leicester, , United Kingdom
University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility, London, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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