Study of SGR-1505 in Mature B-Cell Neoplasms

Phase 1

Recruiting

• Conditions: MALT Lymphoma; Burkitt Lymphoma; Primary Effusion Lymphoma; ALK-Positive Large B-Cell Lymphoma; Mature B-Cell Neoplasm; Non Hodgkin Lymphoma; DLBCL; Follicular Lymphoma; IRF4 Gene Rearrangement; EBV-Positive DLBCL, Nos
• Interventions: Drug: SGR-1505

• Registration Number: NCT05544019
• Lead Sponsor: Schrödinger, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-16
• Study Start: 2023-04-10
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	SGR-1505	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.

Primary Outcome Measures

Name	Time	Method
Nature and number of incidences of dose limiting toxicity (DLT).	The first 21 days.	A DLT is an AE that requires treatment interruption.
Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.	Throughout the study, up to 2 years.

Secondary Outcome Measures

Name	Time	Method
SGR-1505 Time to Maximal Plasma Concentration (tmax)	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).
SGR-1505 Area Under the Concentration Versus Time Curve (AUC)	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).
Objective Response Rate (ORR)	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.
SGR-1505 Maximal Plasma Concentration (Cmax)	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).
Duration of Response (DOR)	Throughout the study, up to 2 years.	The time from response CR/PR until relapse or death from any cause.
Disease Control Rate	Throughout the study, up to 2 years.	PR, CR, and SD for 2 post-baseline disease assessments at least 6 weeks apart.

Trial Locations

Locations (36)

Banner Health - MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

Christiana Care Hospital - Helen F Graham Cancer Center; 🇺🇸 Newark, Delaware, United States

Napa Research; 🇺🇸 Pompano Beach, Florida, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Regional Cancer Care Associates; 🇺🇸 Hackensack, New Jersey, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States

Weill Cornell; 🇺🇸 New York City, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Gabrail Cancer & Research Center; 🇺🇸 Canton, Ohio, United States

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