The primary objective of this study is to determine the safety and tolerability of GS-0189 (formerly FSI-189) as monotherapy and in combination with rituximab in participants with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL).
The study will consist of 5 parts: 1) an initial Monotherapy Dose Escalation (MDE) part, 2) a Combination Dose Escalation (CDE) part, 3) a Pharmacokinetic (PK) Evaluation part, 4) an Alternate Schedule Evaluation (ASE) part and 5) a diffuse large B-cell lymphoma (DLBCL) Expansion part.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0
Time frame: Up to 11 months
Percentage of Participants Experiencing Laboratory Abnormalities
Time frame: Up to 11 months
Pharmacokinetic (PK) Parameter: AUClast of GS-0189
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time frame: Up to 11 months
PK Parameter: AUCtau of GS-0189
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time frame: Up to 11 months
PK Parameter: Cmax of GS-0189
Cmax is defined as the maximum observed concentration of drug.
Time frame: Up to 11 months
PK Parameter: Accumulation Ratio (AR) of GS-0189
AR is defined as ratio based on Cmax and AUCtau after first dose and after multiple doses.
Time frame: Up to 11 months
PK Parameter: Tmax of GS-0189
Tmax is defined as the time (observed time point) of Cmax.
Time frame: Up to 11 months
PK Parameter: AUC0-tau/D Dose-normalized AUCtau of GS-0189
AUC0-tau/D is defined dose normalized area under the concentration-time curve from time zero (pre dose time point of the infusion) to the end of the dosing interval.
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Time frame: Up to 11 months
Percentage of Signal Regulatory Protein Alpha (SIRPα) Receptor Occupancy in the Blood
Time frame: Up to 11 months
Serum Concentration of GS-0189
Time frame: Up to 11 months
Rate of Anti-GS-0189 Antibody Positivity
Time frame: Up to 11 months
Objective response rate (ORR)
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by Lugano Classification response criteria for lymphomas.
Time frame: Up to 2 years
Duration of Response (DOR)
DOR is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression.
Time frame: Up to 2 years
Progression-free Survival (PFS)
PFS is defined as the interval from the first dose date of drug to the earlier of the first documentation of definitive disease progression or death from any cause.
Time frame: Up to 2 years
Overall Survival (OS)
OS is defined as the interval from the first dose date of drug to death from any cause.
Time frame: Up to 2 years
Time to Progression (TTP)
TTP is defined as the interval from the first dose date of drug to the earlier of the first documentation of definitive disease progression.
Time frame: Up to 2 years