A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
Status: Recruiting
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.
• Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks.
Locations
United States
Arizona
Banner Health - MD Anderson Cancer Center
RECRUITING
Gilbert
Delaware
Christiana Care Hospital - Helen F Graham Cancer Center
RECRUITING
Newark
Florida
Napa Research
RECRUITING
Pompano Beach
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
North Carolina
Duke University
RECRUITING
Durham
New Jersey
Regional Cancer Care Associates
RECRUITING
Hackensack
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
Weill Cornell
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Gabrail Cancer & Research Center
RECRUITING
Canton
The Ohio State University - The James Cancer Hospital
RECRUITING
Columbus
Oregon
Oregon Health and Science University - Knight Cancer Institute
RECRUITING
Portland
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Texas
University of Texas Southwestern
RECRUITING
Dallas
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
France
AP-HP Hôpital Henri-Mondor
RECRUITING
Créteil
Institut Gustave Roussy
RECRUITING
Villejuif
Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Presidio Ospedaliero SS Antonio e Biagio e Cesare Arrigo, Ospedale Civile
RECRUITING
Alessandria
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
IRCCS Ospedale San Raffaele
RECRUITING
Milan
AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette
RECRUITING
Torino
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
RECRUITING
Verona
Poland
Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz
RECRUITING
Gdansk
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
RECRUITING
Lodz
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
RECRUITING
Warsaw
Republic of Moldova
Institute of Oncology, ARENSIA Exploratory Medicine
RECRUITING
Chisinau
Romania
ARENSIA Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
RECRUITING
Bucharest
ARENSIA Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
RECRUITING
Cluj-napoca
Spain
Institut Catala d'Oncologia - L'Hospitalet
RECRUITING
Barcelona
Hospital Universitario Quironsalud Madrid
RECRUITING
Madrid
START Madrid - CIOCC
RECRUITING
Madrid
START Madrid - Hospital Fundacion Jimenez Diaz
RECRUITING
Madrid
Clinica Universidad de Navarra - Pamplona
RECRUITING
Pamplona
Hospital Clinico Universitario de Salamanca
RECRUITING
Salamanca
Ukraine
ARENSIA Research Clinic at Harmony Health Clinic
RECRUITING
Kyiv
Contact Information
Primary
Study Physician
sdgr-trials-group@schrodinger.com
+1 (503)-922-0158
Time Frame
Start Date: 2023-04-10
Estimated Completion Date: 2026-03
Participants
Target number of participants: 52
Treatments
Experimental: Dose Escalation
Up to 9 dose levels in total will be evaluated across two dosing schedules. Eligible patients will be assigned to a dose level cohort according to an accelerated titration design that will transition to a traditional 3+3 dose escalation.
Related Therapeutic Areas
Sponsors
Leads: Schrödinger, Inc.