Trial Title:
Study of SGR-1505 in Mature B-Cell Neoplasms
NCT ID:
NCT05544019
Condition:
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
Conditions: Official terms:
Burkitt Lymphoma
Lymphoma
Neoplasms
Lymphoma, Follicular
Lymphoma, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, B-Cell, Marginal Zone
Waldenstrom Macroglobulinemia
Plasmablastic Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Primary Effusion
Conditions: Keywords:
MALT1
NF-kB
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SGR-1505
Description:
SGR-1505 will be administered orally.
Arm group label:
Dose Escalation
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner Health - MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bryan Crabtree
Phone:
480-256-5411
Email:
bryan.crabtree@bannerhealth.com
Facility:
Name:
Christiana Care Hospital - Helen F Graham Cancer Center
Address:
City:
Newark
Zip:
19713
Country:
United States
Status:
Recruiting
Contact:
Last name:
Denise Demaio, BSN, RN
Phone:
302-623-4639
Email:
Denise.A.DeMaio@ChristianaCare.org
Facility:
Name:
Napa Research
Address:
City:
Pompano Beach
Zip:
99064
Country:
United States
Status:
Recruiting
Contact:
Last name:
Magda Hernandez
Phone:
954-773-9890
Email:
mhernandez@napa-trials.com
Investigator:
Last name:
David Kahn, M.D.
Email:
Principal Investigator
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Phone:
617-667-9920
Email:
bmttrials@bidmc.harvard.edu
Facility:
Name:
Regional Cancer Care Associates
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melanie Gonzales
Phone:
732-530-8666
Email:
melaniegonzalez@regionalcancercare.org
Investigator:
Last name:
Iuliana Shapira, M.D.
Email:
Principal Investigator
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Status:
Recruiting
Facility:
Name:
Weill Cornell
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
Gabrail Cancer & Research Center
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carrie Smith, R.N.
Phone:
330-492-3345
Phone ext:
208
Email:
CSmith@GabrailCancerCenter.com
Investigator:
Last name:
Nashat Gabrail, M.D.
Email:
Principal Investigator
Facility:
Name:
The Ohio State University - The James Cancer Hospital
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Phone:
614-366-5643
Investigator:
Last name:
Jennifer Woyach, MD
Email:
Principal Investigator
Facility:
Name:
Oregon Health and Science University - Knight Cancer Institute
Address:
City:
Portland
Zip:
97329
Country:
United States
Status:
Recruiting
Contact:
Last name:
Knight Clinical Trials
Phone:
503-494-1080
Email:
trials@ohsu.edu
Facility:
Name:
Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrew Schumacher
Email:
aschumacher@lifespan.org
Investigator:
Last name:
Adam Olszewski, M.D.
Email:
Principal Investigator
Facility:
Name:
University of Texas Southwestern
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Phone:
206-606-2037
Email:
agopal@uw.edu
Investigator:
Last name:
Ajay Gopal, MD
Email:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Phone:
414-805-8900
Email:
_cccto@mcw.edu
Facility:
Name:
Institute of Oncology, ARENSIA Exploratory Medicine
Address:
City:
Chisinau
Country:
Moldova, Republic of
Status:
Recruiting
Investigator:
Last name:
Vasile Musteata, MD, PhD
Email:
Principal Investigator
Start date:
April 10, 2023
Completion date:
March 2026
Lead sponsor:
Agency:
Schrödinger, Inc.
Agency class:
Industry
Source:
Schrödinger, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05544019
