Study of SGR-1505 in Mature B-Cell Neoplasms

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05544019
• Other study ID #: SGR-1505-101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 10, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Schrödinger, Inc.
• Contact: Study Physician
• Phone: +15032991150
• Email: sdgr-trials-group[@]schrodinger.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-1505.

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) 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 sub-study will evaluate the effect of food and drug-drug interactions. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Life expectancy = 12 weeks.

Exclusion Criteria:

• For a subject with indolent NHL and CLL/SLL, the subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit) and has an indication for treatment.
• 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.

Related Conditions & MeSH terms

• ALK-Positive Large B-Cell Lymphoma
• Burkitt Lymphoma
• Chronic Lymphocytic Leukemia
• DLBCL
• DLBCL Germinal Center B-Cell Type
• EBV-Positive DLBCL, Nos
• Follicular Lymphoma
• High-grade B-cell Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Large-Cell, Immunoblastic
• Lymphoma, Mantle-Cell
• Lymphoplasmacytic Lymphoma
• MALT Lymphoma
• Mantle Cell Lymphoma
• Mature B-Cell Neoplasm
• Neoplasms
• Nodal Marginal Zone Lymphoma
• Non Hodgkin Lymphoma
• Plasmablastic Lymphoma
• Primary Effusion Lymphoma
• Primary Mediastinal Large B Cell Lymphoma
• Splenic Marginal Zone Lymphoma
• Waldenstrom Macroglobulinemia

Intervention

Drug:
• SGR-1505
SGR-1505 will be administered orally.

Locations

Country	Name	City	State
Moldova, Republic of	Institute of Oncology, ARENSIA Exploratory Medicine	Chisinau
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Gabrail Cancer & Research Center	Canton	Ohio
United States	The Ohio State University - The James Cancer Hospital	Columbus	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Banner Health - MD Anderson Cancer Center	Gilbert	Arizona
United States	Regional Cancer Care Associates	Hackensack	New Jersey
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Christiana Care Hospital - Helen F Graham Cancer Center	Newark	Delaware
United States	Napa Research	Pompano Beach	Florida
United States	Oregon Health and Science University - Knight Cancer Institute	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Fred Hutchinson Cancer Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Schrödinger, Inc.

Countries where clinical trial is conducted

United States,  Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Nature and number of incidences of dose limiting toxicity (DLT).	A DLT is an AE that requires treatment interruption.	The first 21 days.
Secondary	SGR-1505 Maximal Plasma Concentration (Cmax)	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.
Secondary	SGR-1505 Time to Maximal Plasma Concentration (tmax)	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.
Secondary	SGR-1505 Area Under the Concentration Versus Time Curve (AUC)	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.
Secondary	Effect of Food on the Cmax of SGR-1505	Plasma exposure parameters for SGR-1505 including, but not limited to, Cmax are evaluated following its administration with and without food.	Throughout the study, up to 2 years.
Secondary	Effect of Food on the tmax of SGR-1505	Plasma exposure parameters for SGR-1505 including, but not limited to, tmax, are evaluated following its administration with and without food.	Throughout the study, up to 2 years.
Secondary	Effect of Food on the AUC of SGR-1505	Plasma exposure parameters for SGR-1505 including, but not limited to, AUC are evaluated following its administration with and without food.	Throughout the study, up to 2 years.
Secondary	Effect of Posaconazole on the Cmax of SGR-1505	Plasma exposure parameters for SGR-1505 including, but not limited to, Cmax are evaluated following its administration alone and after co-administration with Posaconazole, a typical CYP3A4 inhibitor.	Through study completion, up to 2 years.
Secondary	Effect of Posaconazole on the tmax of SGR-1505	Plasma exposure parameters for SGR-1505 including, but not limited to, tmax, are evaluated following its administration alone and after co-administration with Posaconazole, a typical CYP3A4 inhibitor.	Through study completion, up to 2 years.
Secondary	Effect of Posaconazole on the AUC of SGR-1505	Plasma exposure parameters for SGR-1505 including, but not limited to, AUC are evaluated following its administration alone and after co-administration with Posaconazole, a typical CYP3A4 inhibitor.	Through study completion, up to 2 years.
Secondary	Objective Response Rate (ORR)	Number of patients who have a complete response (CR) or partial response (PR) to treatment.	Throughout the study, up to 2 years.
Secondary	Duration of Response (DOR)	The time from response CR/PR until relapse or death from any cause.	Throughout the study, up to 2 years.
Secondary	Disease Control Rate	PR, CR, and SD for 2 post-baseline disease assessments at least 6 weeks apart.	Throughout the study, up to 2 years.