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RecruitingInterventionalPhase 1

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

NCT ID: NCT05544019Sponsor: Schrödinger, Inc.Last updated: 2026-02-13

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.

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.

Arms & interventions

  • DrugSGR-1505

    SGR-1505 will be administered orally.

Outcome measures

Primary

  • 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.

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

    A DLT is an AE that requires treatment interruption.

    Time frame: The first 21 days.

Secondary

  • SGR-1505 Maximal Plasma Concentration (Cmax)

    Time frame: Through study completion, up to 2 years.

  • SGR-1505 Time to Maximal Plasma Concentration (tmax)

    Time frame: 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.

  • Objective Response Rate (ORR)

    Time frame: Throughout the study, up to 2 years.

  • Duration of Response (DOR)

    Time frame: Throughout the study, up to 2 years.

  • Disease Control Rate

    Time frame: Throughout the study, up to 2 years.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (16)

Banner Health - MD Anderson Cancer Center

Gilbert, Arizona, 85234

Recruiting

Christiana Care Hospital - Helen F Graham Cancer Center

Newark, Delaware, 19713

Recruiting
Denise Demaio, BSN, RN · Contact

Napa Research

Pompano Beach, Florida, 99064

Recruiting
Magda Hernandez · Contact
David Kahn, M.D. · Principal Investigator

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Recruiting

Regional Cancer Care Associates

Hackensack, New Jersey, 07601

Recruiting
Iuliana Shapira, M.D. · Principal Investigator

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203

Recruiting

Weill Cornell

New York, New York, 10065

Recruiting

Montefiore Medical Center

The Bronx, New York, 10467

Recruiting

Duke University

Durham, North Carolina, 27710

Recruiting

Gabrail Cancer & Research Center

Canton, Ohio, 44718

Recruiting
Carrie Smith, R.N. · Contact
Nashat Gabrail, M.D. · Principal Investigator

The Ohio State University - The James Cancer Hospital

Columbus, Ohio, 43210

Recruiting
· Contact
Jennifer Woyach, MD · Principal Investigator

Oregon Health and Science University - Knight Cancer Institute

Portland, Oregon, 97329

Recruiting
Knight Clinical Trials · Contact

Rhode Island Hospital

Providence, Rhode Island, 02903

Recruiting
Andrew Schumacher · Contact
Adam Olszewski, M.D. · Principal Investigator

University of Texas Southwestern

Dallas, Texas, 75390

Recruiting

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting
Ajay Gopal, MD · Principal Investigator

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting
Study of SGR-1505 in Mature B-Cell Neoplasms | Cancerify