This research study is studying a new drug, NC410, as a possible treatment for advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
NC410 is an experimental antibody drug that may make the immune response more active against cancer
NIH National Cancer Institute (NCI)
Bethesda, Maryland, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
NYU Langone Health
New York, New York, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Number of Participants With Treatment-emergent Adverse Events
Time frame: From enrollment through up to 90 days after end of treatment, an average of 1 year
Objective Response Rate Per 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 Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors
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 or Modified Response Evaluation Criteria in Solid Tumors 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: CompleteResponse (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 Per 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.
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UT MD Anderson Cancer Center
Houston, Texas, United States
Time frame: Approximately 1 year
Maximum Plasma Concentration (Cmax) of NC410
To evaluate the Maximum Plasma Concentration (Cmax) of NC410
Time frame: Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors
To evaluate progression-free survival (PFS), defined as the time from the first dose of NC410 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), asa 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) as Assessed by Time of Death
To evaluate overall survival (OS), defined as the time from the first dose of NC410 to death due to any cause.
Time frame: Approximately 1 year
Area Under the Curve (AUC) of NC410
To evaluate the Area Under the Curve (AUC) of NC410.
Time frame: Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.
Half-life (t1/2) of NC410
To evaluate the half-life (t1/2) of NC410
Time frame: Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.