Clinical trial NCT05544019: Study of SGR-1505 in Mature B-Cell Neoplasms
Official title: A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Mature B-Cell Neoplasm
Non Hodgkin Lymphoma
DLBCL
Waldenstrom Macroglobulinemia
MALT Lymphoma
Follicular Lymphoma
Pediatric-Type Follicular Lymphoma
IRF4 Gene Rearrangement
EBV-Positive DLBCL, Nos
Burkitt Lymphoma
Plasmablastic Lymphoma
High-grade B-cell Lymphoma
Primary Cutaneous Follicle Center Lymphoma
Primary Effusion Lymphoma
Mantle Cell Lymphoma
DLBCL Germinal Center B-Cell Type
Primary Mediastinal Large B Cell Lymphoma
T-Cell/Histiocyte Rich Lymphoma
ALK-Positive Large B-Cell Lymphoma
Primary Cutaneous Diffuse Large B-Cell Lymphoma
Splenic Marginal Zone Lymphoma
Chronic Lymphocytic Leukemia
Nodal Marginal Zone Lymphoma
HHV8-Positive DLBCL, Nos
Lymphoplasmacytic Lymphoma
Duodenal-Type Follicular Lymphoma
Keywords: MALT1
NF-kB
Lead sponsor: Schrödinger, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.
timeFrame: Throughout the study, up to 2 years.
measure: Nature and number of incidences of dose limiting toxicity (DLT).
timeFrame: The first 21 days.
Secondary outcomes:
measure: SGR-1505 Maximal Plasma Concentration (Cmax)
timeFrame: Through study completion, up to 2 years.
measure: SGR-1505 Time to Maximal Plasma Concentration (tmax)
timeFrame: Through study completion, up to 2 years.
measure: SGR-1505 Area Under the Concentration Versus Time Curve (AUC)
timeFrame: Through study completion, up to 2 years.
measure: Objective Response Rate (ORR)
timeFrame: Throughout the study, up to 2 years.
measure: Duration of Response (DOR)
timeFrame: Throughout the study, up to 2 years.
measure: Disease Control Rate
timeFrame: Throughout the study, up to 2 years.
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner Health - MD Anderson Cancer Center
state: Arizona
city: Newark
country: United States
facility: Christiana Care Hospital - Helen F Graham Cancer Center
state: Delaware
city: Pompano Beach
country: United States
facility: Napa Research
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Hackensack
country: United States
facility: Regional Cancer Care Associates
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer & Research Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University - The James Cancer Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University - Knight Cancer Institute
state: Oregon
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Chisinau
country: Moldova, Republic of
facility: Institute of Oncology, ARENSIA Exploratory Medicine
Study officials:
affiliation: Schrodinger Inc.
name: Frank G Basile, M.D.
role: STUDY_DIRECTOR
References: