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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
SGR-1505 will be administered orally.
Banner Health - MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGChristiana Care Hospital - Helen F Graham Cancer Center
Newark, Delaware, United States
RECRUITINGNapa Research
Pompano Beach, Florida, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
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.
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).
Time frame: Through study completion, up to 2 years.
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).
Time frame: Through study completion, up to 2 years.
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).
Time frame: Through study completion, up to 2 years.
Objective Response Rate (ORR)
Number of patients who have an objective response per response criteria other than stable disease (SD) or progressive disease (PD) to treatment.
Time frame: Throughout the study, up to 2 years.
Duration of Response (DOR)
The time from response CR/PR until relapse or death from any cause.
Time frame: Throughout the study, up to 2 years.
Disease Control Rate
PR, CR, and SD for 2 post-baseline disease assessments at least 6 weeks apart.
Time frame: Throughout the study, up to 2 years.
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Regional Cancer Care Associates
Hackensack, New Jersey, United States
RECRUITINGRoswell Park Comprehensive Cancer Center
Buffalo, New York, United States
RECRUITINGWeill Cornell
New York, New York, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGGabrail Cancer & Research Center
Canton, Ohio, United States
RECRUITING...and 26 more locations