Clinical trial Recruiting at 36 sites Phase 1 Interventional Ages 18 and up

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

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment98 (estimated)
SponsorSchrödinger, Inc.
Industry-sponsored
Locations36 sites (Gilbert, Arizona and 35 other locations)
StatusRecruiting
StartedApril 10, 2023
Main results expectedNovember 2027
Study endsNovember 2027
Registry record updatedFebruary 13, 2026
Trial IDNCT05544019 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

  • 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
  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.