RECRUITING

Study of SGR-1505 in Mature B-Cell Neoplasms

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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 LymphomaMALT1NF-kB

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies

Quick Facts

Study Start:2023-04-10
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05544019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.
  2. * Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.
  3. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. * Life expectancy ≥ 12 weeks.
  1. * The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).
  2. * Subject has previous invasive malignancy in the last 2 years.
  3. * Subject has a known allergy to SGR-1505 or excipients of SGR-1505.
  4. * Subject has symptomatic or active CNS involvement of disease.
  5. * 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.

Contacts and Locations

Study Contact

Study Physician
CONTACT
+1 (503)-922-0158
sdgr-trials-group@schrodinger.com

Principal Investigator

Frank G Basile, M.D.
STUDY_DIRECTOR
Schrodinger Inc.

Study Locations (Sites)

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
Montefiore Medical Center
Bronx, New York, 10467
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
United States
Weill Cornell
New York, New York, 10065
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

Collaborators and Investigators

Sponsor: Schrödinger, Inc.

  • Frank G Basile, M.D., STUDY_DIRECTOR, Schrodinger Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-10
Study Completion Date2026-03

Study Record Updates

Study Start Date2023-04-10
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • MALT1
  • NF-kB

Additional Relevant MeSH Terms

  • 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