Study of SGR-1505 in Mature B-Cell Neoplasms

Last updated: September 13, 2024
Sponsor: Schrödinger, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma, B-cell

Neoplasms

Leukemia

Treatment

SGR-1505

Clinical Study ID

NCT05544019
SGR-1505-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject must have a history of histologically or cytologically confirmed matureB-cell malignancy.

  • Subject must have measurable or detectable disease according to the applicabledisease-specific classification system and meet criteria for initiation oftreatment.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • Life expectancy ≥ 12 weeks.

Exclusion

Exclusion Criteria:

  • The subject is in need of immediate cytoreductive therapy (unless the patient has noremaining 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 clinicallaboratory finding that would place the participant at increased risk to the use ofan investigational drug.

Study Design

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: SGR-1505
Phase: 1
Study Start date:
April 10, 2023
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Institute of Oncology, ARENSIA Exploratory Medicine

    Chisinau,
    Moldova, Republic of

    Active - Recruiting

  • Banner Health - MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • Christiana Care Hospital - Helen F Graham Cancer Center

    Newark, Delaware 19713
    United States

    Active - Recruiting

  • Napa Research

    Pompano Beach, Florida 99064
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Regional Cancer Care Associates

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Weill Cornell

    New York, New York 10065
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Gabrail Cancer & Research Center

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • OSU- The James Cancer Hospital

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • The Ohio State University - The James Cancer Hospital

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Oregon Health and Science University - Knight Cancer Institute

    Portland, Oregon 97329
    United States

    Active - Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.