A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
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.
Arms & interventions
- DrugSGR-1505
SGR-1505 will be administered orally.
Outcome measures
Primary
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.
Nature and number of incidences of dose limiting toxicity (DLT).
A DLT is an AE that requires treatment interruption.
Time frame: The first 21 days.
Secondary
SGR-1505 Maximal Plasma Concentration (Cmax)
Time frame: Through study completion, up to 2 years.
SGR-1505 Time to Maximal Plasma Concentration (tmax)
Time frame: Through study completion, up to 2 years.
SGR-1505 Area Under the Concentration Versus Time Curve (AUC)
Time frame: Through study completion, up to 2 years.
Objective Response Rate (ORR)
Time frame: Throughout the study, up to 2 years.
Duration of Response (DOR)
Time frame: Throughout the study, up to 2 years.
Disease Control Rate
Time frame: Throughout the study, up to 2 years.
Eligibility criteria
Study locations (16)
Banner Health - MD Anderson Cancer Center
Gilbert, Arizona, 85234
Christiana Care Hospital - Helen F Graham Cancer Center
Newark, Delaware, 19713
Napa Research
Pompano Beach, Florida, 99064
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Regional Cancer Care Associates
Hackensack, New Jersey, 07601
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Weill Cornell
New York, New York, 10065
Montefiore Medical Center
The Bronx, New York, 10467
Duke University
Durham, North Carolina, 27710
Gabrail Cancer & Research Center
Canton, Ohio, 44718
The Ohio State University - The James Cancer Hospital
Columbus, Ohio, 43210
Oregon Health and Science University - Knight Cancer Institute
Portland, Oregon, 97329
Rhode Island Hospital
Providence, Rhode Island, 02903
University of Texas Southwestern
Dallas, Texas, 75390
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226