A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.
Start Date
9/5/2024
Completion Date
3/1/2028
Summary
This clinical trial is studying the safety and potential anti-tumor activity of an investigational drug called ARV-393 in patients diagnosed with advanced Relapsed/Refractory non-Hodgkin's lymphoma (R/R NHL) to determine if ARV-393 may be a possible treatment option. ARV-393 is thought to work by breaking down a protein present in many types of non-Hodgkins lymphomas, which may prevent, slow or stop tumor growth. This is the first time ARV-393 will be used by people. The investigational drug will be given as an oral tablet.
Detailed Description
This is an open-label, global, multi-center monotherapy and combination dose escalation and dose optimization study to evaluate safety, tolerability and preliminary efficacy of ARV-393. The study will evaluate the safety and tolerability in ascending doses of ARV-393 as monotherapy (A) and in combination with glofitamab (C), as well as determine the RP2D in the dose optimization parts (B for monotherapy) and in combination with glofitamab (D for combination therapy). The monotherapy portions of the study will include participants with R/R NHL. The combination therapy portions of the study with glofitamab will include participants with R/R DLBCL.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ARV-393
Glofitamab
Conditions
Locations
Clinical Trial Site
New Haven, Connecticut 06510
United States
Clinical Trial Site
Detroit, Michigan 48201
United States
Clinical Trial Site
New Brunswick, New Jersey 10065
United States
Clinical Trial Site
New York, New York 10016
United States
Clinical Trial Site
New York, New York 10021
United States
Clinical Trial Site
Cleveland, Ohio 44122
United States
Clinical Trial Site
Nashville, Tennessee 37203
United States
Clinical Trial Site
Houston, Texas 77030
United States
Clinical Trial Site
Toronto, Ontario M5G 1Z5
Canada
Clinical Trial Site
Montreal, Quebec H3T 1E2
Canada
Clinical Trial Site
Copenhagen, 2100
Denmark
Clinical Trial Site
Odense C, 5000
Denmark
Clinical Trial Site
El Palmar, Murcia 30120
Spain
Clinical Trial Site
Pamplona, Navarre 31008
Spain
Clinical Trial Site
Barcelona, 8908
Spain
Clinical Trial Site
Madrid, 28050
Spain
Clinical Trial Site
Salamanca, 37007
Spain