This was an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. Part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. Part 2 is dose expansion in which Part 1 recommended dose will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Initial cohort dose of INCAGN01876 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Yale University
New Haven, Connecticut, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) and as Per the Severity
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent AE is any AE either reported for first time or worsening of a pre-existing event after the first dose of study drug. Grade 1 AEs is defined as Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 AEs is defined as Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3 AEs is defined as the severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living and Grade 4 AEs as life-threatening consequences; urgent intervention indicated. Data is reported for Grade 3 and higher severity for this outcome measure.
Time frame: From screening through 60 days after end of treatment, up to Month 15
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 of Cycles 1 and 6 post-dose
Time to Maximum Concentration (Tmax)
Time frame: Day 1 of Cycles 1 and 6 post-dose
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin)
Time frame: Day 1 of Cycles 2, 3, 4, 6, and 7 post-dose
Area Under the Plasma Time Curve From Time = 0 to the Last Measurable Concentration (AUC0-t)
Time frame: Day 1 of Cycles 1 and 6 post-dose
Objective Response Rate (ORR) Per RECIST v1.1 and Modified RECISTv1.1 (mRECIST)
ORR is defined as the percentage of participants having complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease assessments. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm.
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Boston, Massachusetts, United States
Memorial Sloan Kettering at Monmouth
Middletown, New Jersey, United States
MSK Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Time frame: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
Duration of Response (DOR) Per RECIST and mRECIST
DOR is defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression, as determined by investigator assessment of radiographic disease assessments per RECIST v1.1 and mRECIST, or death due to any cause if occurring sooner than progression. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm.
Time frame: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
Duration of Disease Control Per RECIST and mRECIST
Duration of disease control (CR, PR, and stable disease \[SD\]), as measured from first report of SD or better until disease progression, as determined by investigator assessment of radiographic disease assessments per RECIST v1.1 and mRECIST, or death due to any cause if occurring sooner than progression. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time frame: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
Progression Free Survival (PFS) Per RECIST and mRECIST
PFS is defined as the time from date of first dose of study drug until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease assessments per RECIST v1.1 and mRECIST, or death due to any cause if occurring sooner than progression. Progression is defined by RECIST and mRECIST as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute lesion increase of at least 5 mm or the appearance of new lesions.
Time frame: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months