Study of SGR-1505 in Mature B-Cell Neoplasms

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.

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

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Study Overview

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Study Details

Study overview

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.

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

Study of SGR-1505 in Mature B-Cell Neoplasms

Condition
Mature B-Cell Neoplasm
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner Health - MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Newark

Christiana Care Hospital - Helen F Graham Cancer Center, Newark, Delaware, United States, 19713

Pompano Beach

Napa Research, Pompano Beach, Florida, United States, 99064

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Hackensack

Regional Cancer Care Associates, Hackensack, New Jersey, United States, 07601

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10467

Buffalo

Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States, 14203

New York

Weill Cornell, New York, New York, United States, 10065

Durham

Duke University, Durham, North Carolina, United States, 27710

Canton

Gabrail Cancer & Research Center, Canton, Ohio, United States, 44718

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Schrödinger, Inc.,

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

Study Record Dates

2026-03