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NCT05544019PHASE1Recruiting

Study of SGR-1505 in Mature B-Cell Neoplasms

Schrödinger, Inc.

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

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.

Interventions

DRUG

SGR-1505

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Conditions

Mature B-Cell NeoplasmNon Hodgkin LymphomaDLBCLWaldenstrom MacroglobulinemiaMALT LymphomaFollicular LymphomaPediatric-Type Follicular LymphomaIRF4 Gene RearrangementEBV-Positive DLBCL, NosBurkitt LymphomaPlasmablastic LymphomaHigh-grade B-cell LymphomaPrimary Cutaneous Follicle Center LymphomaPrimary Effusion LymphomaMantle Cell LymphomaDLBCL Germinal Center B-Cell TypePrimary Mediastinal Large B Cell LymphomaT-Cell/Histiocyte Rich LymphomaALK-Positive Large B-Cell LymphomaPrimary Cutaneous Diffuse Large B-Cell LymphomaSplenic Marginal Zone LymphomaChronic Lymphocytic LeukemiaNodal Marginal Zone LymphomaHHV8-Positive DLBCL, NosLymphoplasmacytic LymphomaDuodenal-Type Follicular Lymphoma

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