Evaluating SGR-1505 for treating mature B-cell neoplasms
Official title: A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
Run by Schrödinger, Inc. · NCT05544019 · Data updated 2026-11-12
This study is testing a new oral medication called SGR-1505 to see if it is safe and effective for people with certain types of B-cell lymphomas that have not responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 98 (estimated) |
| Sponsor | Schrödinger, Inc. Industry-sponsored |
| Locations | 36 sites (Gilbert, Arizona and 35 other locations) |
| Status | Recruiting |
| Started | April 10, 2023 |
| Main results expected | November 2027 |
| Study ends | November 2027 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT05544019 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with relapsed or refractory mature B-cell malignancies who have measurable disease and an ECOG performance status of 0 or 1.
✕Probably not a fit
Patients requiring immediate cytoreductive therapy or those with symptomatic CNS involvement of the disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety and tolerability of SGR-1505, an oral inhibitor of MALT1, in patients with relapsed or refractory B-cell lymphomas. It aims to determine the maximum tolerated dose (MTD) and assess pharmacokinetics (PK) and pharmacodynamics (PD) of the drug. Additionally, exploratory cohorts will investigate preliminary anti-tumor activity and safety, with plans to evaluate SGR-1505 in combination with other anti-cancer agents for specific B-cell malignancies.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.
How similar studies have gone: Other studies have shown promise with similar approaches targeting MALT1, indicating potential for success in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Banner Health - MD Anderson Cancer Center
Gilbert, Arizona, United States Recruiting -
Christiana Care Hospital - Helen F Graham Cancer Center
Newark, Delaware, United States Recruiting -
Napa Research
Pompano Beach, Florida, United States Recruiting -
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting -
Regional Cancer Care Associates
Hackensack, New Jersey, United States Recruiting -
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States Recruiting
Show 30 more locations
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Weill Cornell
New York, New York, United States Recruiting -
Montefiore Medical Center
The Bronx, New York, United States Recruiting -
Duke University
Durham, North Carolina, United States Recruiting -
Gabrail Cancer & Research Center
Canton, Ohio, United States Recruiting -
The Ohio State University - The James Cancer Hospital
Columbus, Ohio, United States Recruiting -
Oregon Health and Science University - Knight Cancer Institute
Portland, Oregon, United States Recruiting -
Rhode Island Hospital
Providence, Rhode Island, United States Recruiting -
University of Texas Southwestern
Dallas, Texas, United States Recruiting -
Fred Hutchinson Cancer Center
Seattle, Washington, United States Recruiting -
Medical College of Wisconsin
Milwaukee, Wisconsin, 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
Study contacts
- Study coordinator: Study Physician
- Email: sdgr-trials-group@schrodinger.com
- Phone: +1 (503)-922-0158
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL
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Treatment for relapsed or refractory B-cell lymphoma using SynKIR-310
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Gene therapy for certain blood cancers
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Using modified T cells to treat relapsed or refractory Non-Hodgkin Lymphoma
This study is testing a new treatment using modified T cells to see if it can help people with relapsed or hard-to-treat Non-Hodgkin Lymphoma.
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Using CAR T cells to treat certain types of B cell lymphomas
This study is testing a new CAR T cell therapy to see if it can help adults with certain types of B cell lymphomas that haven't improved with other treatments.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.