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NCT Number: NCT05544019

Study of SGR-1505 in Mature B-Cell Neoplasms

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.

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Key information

Conditions

Mature B-Cell Neoplasm ALK-Positive Large B-Cell Lymphoma Blood Protein Disorders Burkitt Lymphoma Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia DLBCL DLBCL Germinal Center B-Cell Type DNA Virus Infections Digestive System Diseases Disease Attributes Duodenal-Type Follicular Lymphoma EBV-Positive DLBCL, Nos Epstein-Barr Virus Infections Follicular Lymphoma Gastric Outlet Obstruction Gastrointestinal Diseases HHV8-Positive DLBCL, Nos Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections High-grade B-cell Lymphoma IRF4 Gene Rearrangement Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, Primary Effusion Lymphoplasmacytic Lymphoma Lymphoproliferative Disorders MALT Lymphoma Mantle Cell Lymphoma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nodal Marginal Zone Lymphoma Non Hodgkin Lymphoma Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric-Type Follicular Lymphoma Plasmablastic Lymphoma Primary Cutaneous Diffuse Large B-Cell Lymphoma Primary Cutaneous Follicle Center Lymphoma Primary Effusion Lymphoma Primary Mediastinal Large B Cell Lymphoma Pyloric Stenosis Pyloric Stenosis, Hypertrophic Splenic Marginal Zone Lymphoma Stomach Diseases T-Cell/Histiocyte Rich Lymphoma Tumor Virus Infections Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AP-HP Hôpital Henri-Mondor, Créteil, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SGR-1505

Drug

SGR-1505 will be administered orally.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Physician

CONTACT

[email protected]

+1 (503)-922-0158

Sponsors and collaborators

Lead sponsor

Schrödinger, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2022
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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