Study of SGR-1505 in Mature B-Cell Neoplasms

NCT05544019 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SGR-1505-101
• Study Type: interventional
• Target: 98
• Locations: 8 countries
• Sites: 36

Brief 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.

Conditions

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

MALT1; NF-kB; Waldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (2)

• 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).

  A DLT is an AE that requires treatment interruption.

  The first 21 days.

Secondary Outcomes (6)

• SGR-1505 Maximal Plasma Concentration (Cmax)

  Through study completion, up to 2 years.

• SGR-1505 Time to Maximal Plasma Concentration (tmax)

  Through study completion, up to 2 years.

• SGR-1505 Area Under the Concentration Versus Time Curve (AUC)

  Through study completion, up to 2 years.

• Objective Response Rate (ORR)

  Throughout the study, up to 2 years.

• Duration of Response (DOR)

  Throughout the study, up to 2 years.

Study Arms (1)

Dose Escalation

EXPERIMENTAL

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.

Drug: SGR-1505

Interventions

SGR-1505 DRUG

SGR-1505 will be administered orally.

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Schrödinger, Inc.: lead

Study Sites (36)

Banner Health - MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

Christiana Care Hospital - Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

RECRUITING

Napa Research

Pompano Beach, Florida, 99064, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Regional Cancer Care Associates

Hackensack, New Jersey, 07601, United States

RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

RECRUITING

Weill Cornell

New York, New York, 10065, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Gabrail Cancer & Research Center

Canton, Ohio, 44718, United States

RECRUITING

The Ohio State University - The James Cancer Hospital

Columbus, Ohio, 43210, United States

RECRUITING

Oregon Health and Science University - Knight Cancer Institute

Portland, Oregon, 97329, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

AP-HP Hôpital Henri-Mondor

Créteil, France

RECRUITING

Institut Gustave Roussy

Villejuif, France

RECRUITING

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

Alessandria, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

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

Torino, Italy

RECRUITING

Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma

Verona, Italy

RECRUITING

Institute of Oncology, ARENSIA Exploratory Medicine

Chisinau, Moldova

RECRUITING

Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz

Gdansk, Poland

RECRUITING

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

Lodz, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

Warsaw, Poland

RECRUITING

ARENSIA Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti

Bucharest, Romania

RECRUITING

ARENSIA Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca

Cluj-Napoca, Romania

RECRUITING

Institut Catala d'Oncologia - L'Hospitalet

Barcelona, Spain

RECRUITING

Hospital Universitario Quironsalud Madrid

Madrid, Spain

RECRUITING

START Madrid - CIOCC

Madrid, Spain

RECRUITING

START Madrid - Hospital Fundacion Jimenez Diaz

Madrid, Spain

RECRUITING

Clinica Universidad de Navarra - Pamplona

Pamplona, Spain

RECRUITING

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

RECRUITING

ARENSIA Research Clinic at Harmony Health Clinic

Kyiv, Ukraine

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Waldenstrom Macroglobulinemia; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Follicular; Pyloric Stenosis, Hypertrophic; Burkitt Lymphoma; Plasmablastic Lymphoma; Lymphoma, Primary Effusion; Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoma, B-Cell; Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, Large B-Cell, Diffuse; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank G Basile, M.D.

  Schrodinger Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Physician

CONTACT

+1 (503)-922-0158; sdgr-trials-group@schrodinger.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: September 16, 2022
• Study Start: April 10, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); UA (1); PL (3); MO (1); US (16); RO (2); IT (5); ES (6)