The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
INCAGN02385 administered as an intravenous infusion over 30 minutes.
The Angeles Clinic and Research Center
Los Angeles, California, United States
Hackensack Medical Center
Hackensack, New Jersey, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Number of treatment-emergent adverse events (TEAEs)
TEAE defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time frame: Up to 12 months
Cmax of INCAGN02385
Maximum observed plasma concentration.
Time frame: Up to 12 months
Tmax of INCAGN02385
Time to maximum plasma concentration.
Time frame: Up to 12 months
Cmin of INCAGN02385
Minimum observed plasma concentration during the dosing interval.
Time frame: Up to 12 months
AUC0-t of INCAGN02385
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration.
Time frame: Up to 12 months
Objective response rate (ORR) in participants with advanced or metastatic solid tumors
Defined as the percentage of participants having complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to 12 months
Disease control rate (DCR) in participants with advanced or metastatic solid tumors
Defined as percentage of participants having CR, PR, or stable disease (SD) as best on-study response.
Time frame: Up to 12 months
Duration of response (DOR) in participants with advanced or metastatic solid tumors
Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression per RECIST v1.1 or death from any cause, if occurring sooner than progression.
Time frame: Up to 12 months
Progression-free survival (PFS) in participants with advanced or metastatic solid tumors
Defined as the time from date of first dose of study drug until the earliest date of disease progression per RECIST v1.1 or death from any cause if occurring sooner than progression.
Time frame: Up to 12 months
ORR in participants with diffuse large B-cell lymphoma (DLBCL)
Defined as the percentage of participants with a CR/complete metabolic response (CMR) or PR/partial metabolic response (PMR) per the Lugano Classification.
Time frame: Up to 12 months
DOR in participants with DLBCL
Defined as the time from first documented evidence of CR/CMR or PR/PMR until disease progression per radiographic disease assessment or death from any cause among participants who achieve an objective response.
Time frame: Up to 12 months
PFS in participants with DLBCL
Defined as the time from the date of the first dose of study drug until the earliest date of disease progression per radiographic disease assessment or death from any cause if occurring sooner than progression.
Time frame: Up to 12 months
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