This research study is studying a new drug, NC762, as a possible treatment for advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
NC762 is an experimental antibody drug that may make the immune response more active against cancer
Yale Cancer Center
New Haven, Connecticut, United States
The University of Chicago Medicine and Biological Sciences
Chicago, Illinois, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Frequency, duration, and severity of treatment-emergent adverse events (AEs)
Time frame: From enrollment through up to 90 days after end of treatment, an average of 1 year
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 1 year
Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 to the first documented progressive disease or death due to any cause, whichever occurs first. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Time frame: Approximately 1 year
Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Approximately 1 year
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Roswell Park Cancer Institute
Buffalo, New York, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To evaluate progression-free survival (PFS), defined as the time from the first dose of NC762 to the first occurrence of documented progressive disease or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Approximately 1 year
Overall Survival (OS)
To evaluate overall survival (OS), defined as the time from the first dose of NC762 to death due to any cause.
Time frame: Approximately 1 year
Maximum Serum Concentration (Cmax) of NC762
To evaluate the Maximum Serum Concentration (Cmax) of NC762
Time frame: Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days.
Area Under the Curve (AUC) of NC762
To evaluate the Area Under the Curve (AUC) of NC762
Time frame: Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days.
Half-life (T1/2) of NC762
To evaluate the Half-life (T1/2) of NC762
Time frame: Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days.