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Mature B-Cell NeoplasmPhase 1NCT05544019

Study of SGR-1505 in Mature B-Cell Neoplasms

A Phase 1 study testing SGR-1505 in people with Mature B-Cell Neoplasm and Non Hodgkin Lymphoma, run by Schrödinger, Inc. at 36 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SGR-1505
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
36 sitesin 8 countries
Study dates
10 Apr 2023to Nov 2027
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

36 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Study Physician contact

+1 (503)-922-0158

sdgr-trials-group@schrodinger.com

36 sites in 8 countries

United States16 sites, 16 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

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

    Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14203

    Recruiting

  • Gabrail Cancer & Research Center

    Canton, Ohio, 44718

    Carrie Smith, R.N., 330-492-3345 ext. 208, CSmith@GabrailCancerCenter.com

    Nashat Gabrail, M.D.

    Recruiting

  • The Ohio State University - The James Cancer Hospital

    Columbus, Ohio, 43210

    614-366-5643

    Jennifer Woyach, MD

    Recruiting

  • University of Texas Southwestern

    Dallas, Texas, 75390

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Recruiting

  • Banner Health - MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Bryan Crabtree, 480-256-5411, bryan.crabtree@bannerhealth.com

    Recruiting

  • Regional Cancer Care Associates

    Hackensack, New Jersey, 07601

    Melanie Gonzales, 732-530-8666, melaniegonzalez@regionalcancercare.org

    Iuliana Shapira, M.D.

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    414-805-8900, _cccto@mcw.edu

    Recruiting

  • Weill Cornell

    New York, New York, 10065

    Recruiting

  • Christiana Care Hospital - Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Denise Demaio, BSN, RN, 302-623-4639, Denise.A.DeMaio@ChristianaCare.org

    Recruiting

  • Napa Research

    Pompano Beach, Florida, 99064

    Magda Hernandez, 954-773-9890, mhernandez@napa-trials.com

    David Kahn, M.D.

    Recruiting

  • Oregon Health and Science University - Knight Cancer Institute

    Portland, Oregon, 97329

    Knight Clinical Trials, 503-494-1080, trials@ohsu.edu

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Andrew Schumacher, aschumacher@lifespan.org

    Adam Olszewski, M.D.

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    206-606-2037, agopal@uw.edu

    Ajay Gopal, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Recruiting

Other trials in United States

Spain6 sites, 6 recruiting

  • Institut Catala d'Oncologia - L'Hospitalet

    Barcelona

    Recruiting

  • Hospital Universitario Quironsalud Madrid

    Madrid

    Recruiting

  • START Madrid - CIOCC

    Madrid

    Recruiting

  • START Madrid - Hospital Fundacion Jimenez Diaz

    Madrid

    Recruiting

  • Clinica Universidad de Navarra - Pamplona

    Pamplona

    Recruiting

  • Hospital Clinico Universitario de Salamanca

    Salamanca

    Recruiting

Other trials in Spain

Italy5 sites, 5 recruiting

  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Presidio Ospedaliero SS Antonio e Biagio e Cesare Arrigo, Ospedale Civile

    Alessandria

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan

    Recruiting

  • AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette

    Torino

    Recruiting

  • Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma

    Verona

    Recruiting

Other trials in Italy

Poland3 sites, 3 recruiting

  • Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz

    Gdansk

    Recruiting

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    Lodz

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

    Warsaw

    Recruiting

Other trials in Poland

France2 sites, 2 recruiting

  • AP-HP Hôpital Henri-Mondor

    Créteil

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Recruiting

Other trials in France

Romania2 sites, 2 recruiting

  • ARENSIA Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti

    Bucharest

    Recruiting

  • ARENSIA Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca

    Cluj-Napoca

    Recruiting

Other trials in Romania

Moldova1 site, 1 recruiting

  • Institute of Oncology, ARENSIA Exploratory Medicine

    Chisinau

    Vasile Musteata, MD, PhD

    Recruiting

Other trials in Moldova

Ukraine1 site, 1 recruiting

  • ARENSIA Research Clinic at Harmony Health Clinic

    Kyiv

    Recruiting

Other trials in Ukraine

About this study

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

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.

Read the detailed description

This is a study of SGR-1505, an oral inhibitor of MALT1, in subjects with relapsed/refractory (R/R) B-cell lymphomas to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505. Exploratory cohorts will evaluate additional PK, PD, preliminary anti-tumor activity, and safety to establish the SGR-1505 RD. A planned amendment will evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.

Being tested
SGR-1505
Keywords
MALT1, NF-kB, Waldenstrom Macroglobulinemia
Medical subject headings
Lymphoma, Non-Hodgkin, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular, Pyloric Stenosis, Hypertrophic, Burkitt Lymphoma, Plasmablastic Lymphoma, Lymphoma, Primary Effusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGR-1505Drug

    SGR-1505 will be administered orally.

Study groups in NCT05544019
Study groupRoleWhat they receive
Dose EscalationExperimentalUp 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.
Receives: Drug: SGR-1505

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.

    Measured: Throughout the study, up to 2 years.

  2. Nature and number of incidences of dose limiting toxicity (DLT).

    A DLT is an AE that requires treatment interruption.

    Measured: The first 21 days.

Secondary outcomes (6)

  1. SGR-1505 Maximal Plasma Concentration (Cmax)

    Concentrations of SGR-1505 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the maximal plasma concentration (Cmax).

    Measured: Through study completion, up to 2 years.

  2. SGR-1505 Time to Maximal Plasma Concentration (tmax)

    Concentrations of SGR-1505 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the time to maximal plasma concentration (tmax).

    Measured: Through study completion, up to 2 years.

  3. SGR-1505 Area Under the Concentration Versus Time Curve (AUC)

    Concentrations of SGR-1505 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the area under the concentration versus time curve (AUC).

    Measured: Through study completion, up to 2 years.

  4. Objective Response Rate (ORR)

    Number of patients who have an objective response per response criteria other than stable disease (SD) or progressive disease (PD) to treatment.

    Measured: Throughout the study, up to 2 years.

  5. Duration of Response (DOR)

    The time from response CR/PR until relapse or death from any cause.

    Measured: Throughout the study, up to 2 years.

  6. Disease Control Rate

    PR, CR, and SD for 2 post-baseline disease assessments at least 6 weeks apart.

    Measured: Throughout the study, up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start10 Apr 2023
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05544019
Sponsor's protocol ID
SGR-1505-101
Status last verified
Feb 2026
First submitted
19 Aug 2022
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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