Recruiting

Phase 1

SGR-1505Study of SGR-1505 in Mature B-Cell Neoplasms

Sponsor:

Schrödinger, Inc.

Code:

NCT05544019

Conditions

Mature B-Cell Neoplasm

Non Hodgkin Lymphoma

DLBCL

Waldenstrom Macroglobulinemia

MALT Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SGR-1505

Study Details

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

Study ID

NCT05544019

Start date

Apr 10, 2023

Status verified date

Feb, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

98 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

SGR-1505

SGR-1505 will be administered orally.

Primary outcome measure

Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation. [ Time Frame: Throughout the study, up to 2 years. ]
Nature and number of incidences of dose limiting toxicity (DLT). [ Time Frame: The first 21 days. ]

Central Contacts and Locations

Central contacts

Study Physician

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

Locations

Banner Health - MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Bryan Crabtree

480-256-5411 bryan.crabtree@bannerhealth.com

Christiana Care Hospital - Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Denise Demaio, BSN, RN

302-623-4639 Denise.A.DeMaio@ChristianaCare.org

Napa Research

Recruiting

Pompano Beach, Florida, United States, 99064

Contacts

Magda Hernandez

954-773-9890 mhernandez@napa-trials.com

Principal Investigator:

David Kahn, M.D.

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

617-667-9920 bmttrials@bidmc.harvard.edu

Regional Cancer Care Associates

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Melanie Gonzales

732-530-8666 melaniegonzalez@regionalcancercare.org

Principal Investigator:

Iuliana Shapira, M.D.

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14203

Weill Cornell

Recruiting

New York, New York, United States, 10065

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Gabrail Cancer & Research Center

Recruiting

Canton, Ohio, United States, 44718

Contacts

Carrie Smith, R.N.

330-492-3345 CSmith@GabrailCancerCenter.com

Principal Investigator:

Nashat Gabrail, M.D.

The Ohio State University - The James Cancer Hospital

Recruiting

Columbus, Ohio, United States, 43210

Contacts

614-366-5643

Principal Investigator:

Jennifer Woyach, MD

Oregon Health and Science University - Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97329

Contacts

Knight Clinical Trials

503-494-1080 trials@ohsu.edu

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Andrew Schumacher

aschumacher@lifespan.org

Principal Investigator:

Adam Olszewski, M.D.

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

206-606-2037 agopal@uw.edu

Principal Investigator:

Ajay Gopal, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

414-805-8900 _cccto@mcw.edu

More Information

Sponsor

Schrödinger, Inc.

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

MALT1
NF-kB
Waldenstrom Macroglobulinemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Schrödinger, Inc. on 2026-02-13.