Study of SGR-1505 in Mature B-Cell Neoplasms
Start Date
4/10/2023
Completion Date
11/1/2027
Summary
The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505.
Detailed Description
This is a study of SGR-1505, an oral inhibitor of MALT1, in subjects with relapsed/refractory (R/R) B-cell lymphomas to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505. Exploratory cohorts will evaluate additional PK, PD, preliminary anti-tumor activity, and safety to establish the SGR-1505 RD. A planned amendment will evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
SGR-1505
Conditions
Locations
Banner Health - MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Christiana Care Hospital - Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Napa Research
Pompano Beach, Florida 99064
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Regional Cancer Care Associates
Hackensack, New Jersey 07601
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203
United States
Weill Cornell
New York, New York 10065
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Duke University
Durham, North Carolina 27710
United States
Gabrail Cancer & Research Center
Canton, Ohio 44718
United States
The Ohio State University - The James Cancer Hospital
Columbus, Ohio 43210
United States
Oregon Health and Science University - Knight Cancer Institute
Portland, Oregon 97329
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
University of Texas Southwestern
Dallas, Texas 75390
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
AP-HP Hôpital Henri-Mondor
Créteil,
France
Institut Gustave Roussy
Villejuif,
France
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Presidio Ospedaliero SS Antonio e Biagio e Cesare Arrigo, Ospedale Civile
Alessandria,
Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan,
Italy
IRCCS Ospedale San Raffaele
Milan,
Italy
AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette
Torino,
Italy
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
Verona,
Italy
Institute of Oncology, ARENSIA Exploratory Medicine
Chisinau,
Moldova
Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz
Gdansk,
Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz,
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
Warsaw,
Poland
ARENSIA Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Bucharest,
Romania
ARENSIA Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
Cluj-Napoca,
Romania
Institut Catala d'Oncologia - L'Hospitalet
Barcelona,
Spain
Hospital Universitario Quironsalud Madrid
Madrid,
Spain
START Madrid - CIOCC
Madrid,
Spain
START Madrid - Hospital Fundacion Jimenez Diaz
Madrid,
Spain
Clinica Universidad de Navarra - Pamplona
Pamplona,
Spain
Hospital Clinico Universitario de Salamanca
Salamanca,
Spain
ARENSIA Research Clinic at Harmony Health Clinic
Kyiv,
Ukraine