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Study of SGR-1505 in Mature B-Cell Neoplasms

NCT05544019 · Schrödinger, Inc.
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Official title
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
About this study
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
Inclusion Criteria: * 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. Exclusion Criteria: * The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit). * Subject has previous invasive malignancy in the last 2 years. * Subject has a known allergy to SGR-1505 or excipients of SGR-1505. * Subject has symptomatic or active CNS involvement of disease. * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.
Study design
Enrollment target: 98 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-04-10
Estimated completion: 2027-11
Last updated: 2026-02-13
Interventions
Drug: SGR-1505
Primary outcomes
  • Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation. (Throughout the study, up to 2 years.)
  • Nature and number of incidences of dose limiting toxicity (DLT). (The first 21 days.)
Sponsor
Schrödinger, Inc. · industry
Contacts & investigators
ContactStudy Physician · contact · sdgr-trials-group@schrodinger.com · +1 (503)-922-0158
InvestigatorFrank G Basile, M.D. · study_director, Schrodinger Inc.
All locations (36)
Banner Health - MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
Christiana Care Hospital - Helen F Graham Cancer CenterRecruiting
Newark, Delaware, United States
Napa ResearchRecruiting
Pompano Beach, Florida, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Regional Cancer Care AssociatesRecruiting
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer CenterRecruiting
Buffalo, New York, United States
Weill CornellRecruiting
New York, New York, United States
Montefiore Medical CenterRecruiting
The Bronx, New York, United States
Duke UniversityRecruiting
Durham, North Carolina, United States
Gabrail Cancer & Research CenterRecruiting
Canton, Ohio, United States
The Ohio State University - The James Cancer HospitalRecruiting
Columbus, Ohio, United States
Oregon Health and Science University - Knight Cancer InstituteRecruiting
Portland, Oregon, United States
Rhode Island HospitalRecruiting
Providence, Rhode Island, United States
University of Texas SouthwesternRecruiting
Dallas, Texas, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
AP-HP Hôpital Henri-MondorRecruiting
Créteil, France
Institut Gustave RoussyRecruiting
Villejuif, France
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Presidio Ospedaliero SS Antonio e Biagio e Cesare Arrigo, Ospedale CivileRecruiting
Alessandria, Italy
ASST Grande Ospedale Metropolitano NiguardaRecruiting
Milan, Italy
IRCCS Ospedale San RaffaeleRecruiting
Milan, Italy
AOU Citta della Salute e della Scienza di Torino - Ospedale le MolinetteRecruiting
Torino, Italy
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo RomaRecruiting
Verona, Italy
Institute of Oncology, ARENSIA Exploratory MedicineRecruiting
Chisinau, Moldova
Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych FazRecruiting
Gdansk, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w LodziRecruiting
Lodz, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-CurieRecruiting
Warsaw, Poland
ARENSIA Institutul Oncologic Prof. Dr. Alexandru Trestioreanu BucurestiRecruiting
Bucharest, Romania
ARENSIA Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj NapocaRecruiting
Cluj-Napoca, Romania
Institut Catala d'Oncologia - L'HospitaletRecruiting
Barcelona, Spain
Hospital Universitario Quironsalud MadridRecruiting
Madrid, Spain
START Madrid - CIOCCRecruiting
Madrid, Spain
START Madrid - Hospital Fundacion Jimenez DiazRecruiting
Madrid, Spain
Clinica Universidad de Navarra - PamplonaRecruiting
Pamplona, Spain
Hospital Clinico Universitario de SalamancaRecruiting
Salamanca, Spain
ARENSIA Research Clinic at Harmony Health ClinicRecruiting
Kyiv, Ukraine
Study of SGR-1505 in Mature B-Cell Neoplasms · TrialPath