The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Part 1: INCAGN02390 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation in 7 total cohorts to determine the maximum tolerated dose or PAD.
The Angeles Clinical and Research Institute
Los Angeles, California, United States
University of Mississippi
Jackson, Mississippi, United States
Hackensack Medical Center
Hackensack, New Jersey, United States
Carolina BioOncology
Huntsville, North Carolina, United States
Number of treatment-emergent adverse events
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
Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only)
PAD defined as a dose that achieves a level of receptor occupancy considered to be biologically active.
Time frame: Up to approximately 1 month
Cmax of INCAGN02390
Maximum observed plasma or serum concentration.
Time frame: Up to 12 months
Tmax of INCAGN02390
Time to maximum concentration.
Time frame: Up to 12 months
Cmin of INCAGN02390
Minimum observed plasma or serum concentration over the dose interval.
Time frame: Up to 12 months
AUC0-t of INCAGN02390
Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Time frame: Up to 12 months
Objective response rate
Defined as the percentage of participants having complete response (CR) or partial response (PR) determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to 12 months
Duration of response
Defined as time from earliest date of disease response (CR or PR) until earliest date of disease progression (determined by investigator assessment of radiographic disease per RECIST v1.1) or death from any cause, if occurring sooner than progression.
Time frame: Up to 12 months
Disease control rate
Defined as percentage of participants having CR, PR, or stable disease as best on-study response.
Time frame: Up to 12 months
Progression-free survival
Defined as the time from date of first dose of study drug until the earliest date of disease progression (determined by investigator assessment of objective radiographic disease per RECIST v1.1) or death from any cause if occurring sooner than progression.
Time frame: Up to 12 months
Level of binding of INCAGN02390 to TIM-3
Assessed from participant whole blood samples.
Time frame: Up to approximately 3 months
Immunogenicity of INCAGN02390
Defined as the occurrence of specific ADA to INCAGN02390.
Time frame: Up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.