Study of SGR-1505 in Mature B-Cell Neoplasms

February 11, 2026 updated by: Schrödinger, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Créteil, France
        • Recruiting
        • AP-HP Hôpital Henri-Mondor
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy
  • Italy
      • Alessandria, Italy
        • Recruiting
        • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Presidio Ospedaliero SS Antonio e Biagio e Cesare Arrigo, Ospedale Civile
      • Milan, Italy
        • Recruiting
        • IRCCS Ospedale San Raffaele
      • Milan, Italy
        • Recruiting
        • Asst Grande Ospedale Metropolitano Niguarda
      • Torino, Italy
        • Recruiting
        • AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette
      • Verona, Italy
        • Recruiting
        • Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
  • Moldova
      • Chisinau, Moldova
        • Recruiting
        • Institute of Oncology, ARENSIA Exploratory Medicine
        • Principal Investigator:
          • Vasile Musteata, MD, PhD
  • Poland
      • Gdansk, Poland
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz
      • Lodz, Poland
        • Recruiting
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
      • Warsaw, Poland
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
  • Romania
      • Bucharest, Romania
        • Recruiting
        • ARENSIA Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
      • Cluj-Napoca, Romania
        • Recruiting
        • ARENSIA Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Institut Catala d'Oncologia - L'Hospitalet
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Quironsalud Madrid
      • Madrid, Spain
        • Recruiting
        • START Madrid - CIOCC
      • Madrid, Spain
        • Recruiting
        • START Madrid - Hospital Fundacion Jimenez Diaz
      • Pamplona, Spain
        • Recruiting
        • Clinica Universidad de Navarra - Pamplona
      • Salamanca, Spain
        • Recruiting
        • Hospital Clinico Universitario de Salamanca
  • Ukraine
      • Kyiv, Ukraine
        • Recruiting
        • ARENSIA Research Clinic at Harmony Health Clinic
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
    • Delaware
      • Newark, Delaware, United States, 19713
    • Florida
      • Pompano Beach, Florida, United States, 99064
        • Recruiting
        • NAPA Research
        • Contact:
        • Principal Investigator:
          • David Kahn, M.D.
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Roswell Park Comprehensive Cancer Center
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer & Research Center
        • Contact:
        • Principal Investigator:
          • Nashat Gabrail, M.D.
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University - The James Cancer Hospital
        • Contact:
          • Phone Number: 614-366-5643
        • Principal Investigator:
          • Jennifer Woyach, MD
    • Oregon
      • Portland, Oregon, United States, 97329
        • Recruiting
        • Oregon Health and Science University - Knight Cancer Institute
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
        • Principal Investigator:
          • Adam Olszewski, M.D.
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
        • Principal Investigator:
          • Ajay Gopal, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: SGR-1505
SGR-1505 will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Throughout the study, up to 2 years.
Nature and number of incidences of dose limiting toxicity (DLT).
Time Frame: The first 21 days.
A DLT is an AE that requires treatment interruption.
The first 21 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SGR-1505 Maximal Plasma Concentration (Cmax)
Time Frame: Through study completion, up to 2 years.
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).
Through study completion, up to 2 years.
SGR-1505 Time to Maximal Plasma Concentration (tmax)
Time Frame: Through study completion, up to 2 years.
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).
Through study completion, up to 2 years.
SGR-1505 Area Under the Concentration Versus Time Curve (AUC)
Time Frame: Through study completion, up to 2 years.
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).
Through study completion, up to 2 years.
Duration of Response (DOR)
Time Frame: Throughout the study, up to 2 years.
The time from response CR/PR until relapse or death from any cause.
Throughout the study, up to 2 years.
Disease Control Rate
Time Frame: Throughout the study, up to 2 years.
PR, CR, and SD for 2 post-baseline disease assessments at least 6 weeks apart.
Throughout the study, up to 2 years.
Objective Response Rate (ORR)
Time Frame: Throughout the study, up to 2 years.
Number of patients who have an objective response per response criteria other than stable disease (SD) or progressive disease (PD) to treatment.
Throughout the study, up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schrödinger, Inc.

Investigators

  • Study Director: Frank G Basile, M.D., Schrodinger Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGR-1505-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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