MedDataX Logo

Study of SGR-1505 in Mature B-Cell Neoplasms

NCT ID: NCT05544019

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mature B-Cell Neoplasm Non Hodgkin Lymphoma DLBCL Waldenstrom Macroglobulinemia MALT Lymphoma Follicular Lymphoma Pediatric-Type Follicular Lymphoma IRF4 Gene Rearrangement EBV-Positive DLBCL, Nos Burkitt Lymphoma Plasmablastic Lymphoma High-grade B-cell Lymphoma Primary Cutaneous Follicle Center Lymphoma Primary Effusion Lymphoma Mantle Cell Lymphoma DLBCL Germinal Center B-Cell Type Primary Mediastinal Large B Cell Lymphoma T-Cell/Histiocyte Rich Lymphoma ALK-Positive Large B-Cell Lymphoma Primary Cutaneous Diffuse Large B-Cell Lymphoma Splenic Marginal Zone Lymphoma Chronic Lymphocytic Leukemia Nodal Marginal Zone Lymphoma HHV8-Positive DLBCL, Nos Lymphoplasmacytic Lymphoma Duodenal-Type Follicular Lymphoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

MALT1 NF-kB Waldenstrom Macroglobulinemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

SGR-1505

Intervention Type DRUG

SGR-1505 will be administered orally.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SGR-1505

SGR-1505 will be administered orally.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Schrödinger, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frank G Basile, M.D.

Role: STUDY_DIRECTOR

Schrodinger Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Banner Health - MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status RECRUITING

Christiana Care Hospital - Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status RECRUITING

Napa Research

Pompano Beach, Florida, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Regional Cancer Care Associates

Hackensack, New Jersey, United States

Site Status RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Site Status RECRUITING

Weill Cornell

New York, New York, United States

Site Status RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Duke University

Durham, North Carolina, United States

Site Status RECRUITING

Gabrail Cancer & Research Center

Canton, Ohio, United States

Site Status RECRUITING

The Ohio State University - The James Cancer Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Oregon Health and Science University - Knight Cancer Institute

Portland, Oregon, United States

Site Status RECRUITING

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

University of Texas Southwestern

Dallas, Texas, United States

Site Status RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

AP-HP Hôpital Henri-Mondor

Créteil, , France

Site Status RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Presidio Ospedaliero SS Antonio e Biagio e Cesare Arrigo, Ospedale Civile

Alessandria, , Italy

Site Status RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status RECRUITING

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette

Torino, , Italy

Site Status RECRUITING

Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma

Verona, , Italy

Site Status RECRUITING

Institute of Oncology, ARENSIA Exploratory Medicine

Chisinau, , Moldova

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz

Gdansk, , Poland

Site Status RECRUITING

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, , Poland

Site Status RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

Warsaw, , Poland

Site Status RECRUITING

ARENSIA Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti

Bucharest, , Romania

Site Status RECRUITING

ARENSIA Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca

Cluj-Napoca, , Romania

Site Status RECRUITING

Institut Catala d'Oncologia - L'Hospitalet

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Quironsalud Madrid

Madrid, , Spain

Site Status RECRUITING

START Madrid - CIOCC

Madrid, , Spain

Site Status RECRUITING

START Madrid - Hospital Fundacion Jimenez Diaz

Madrid, , Spain

Site Status RECRUITING

Clinica Universidad de Navarra - Pamplona

Pamplona, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Salamanca

Salamanca, , Spain

Site Status RECRUITING

ARENSIA Research Clinic at Harmony Health Clinic

Kyiv, , Ukraine

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States France Italy Moldova Poland Romania Spain Ukraine

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Study Physician

Role: CONTACT

Phone: +1 (503)-922-0158

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bryan Crabtree

Role: primary

Denise Demaio, BSN, RN

Role: primary

Magda Hernandez

Role: primary

Role: primary

Melanie Gonzales

Role: primary

Carrie Smith, R.N.

Role: primary

Role: primary

Knight Clinical Trials

Role: primary

Andrew Schumacher

Role: primary

Role: primary

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SGR-1505-101

Identifier Type: -

Identifier Source: org_study_id