The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Initial cohort dose of INCAGN01949 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.
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, United States
New York University Clinical Cancer Center
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Number of Participants With Treatment-related Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Time frame: From screening through 60 days after end of treatment, up to 11 months
Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Objective Response Rate Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Time frame: Baseline and every 8 weeks,up to 11 months
Duration of Response Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Time frame: Baseline and every 8 weeks, up to 11 months
Progression-free Survival Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
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Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain
University Hospital of Laussane (CHUV)
Lausanne, Switzerland
University College Hospital
London, United Kingdom
University of Oxford
Oxford, United Kingdom
Time frame: Baseline and every 8 weeks, up to 11 months
Duration of Disease Control Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Time frame: Baseline and every 8 weeks, up to 11 months
Time to Maximum Concentration of INCAGN01949 in Plasma
To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Summary of Trough Concentrations(Cmin) of INCAGN01949
To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6