Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21day cycle.
Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21-day cycle. Multiple dose levels will be evaluated. Drug: NGM438 NGM438 is given intravenously (IV) every 3 weeks in a 21-day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21-day cycle.
NGM Clinical Study Site
Gilbert, Arizona, United States
NGM Clinical Study Site
Los Angeles, California, United States
NGM Clinical Study Site
Sarasota, Florida, United States
NGM Clinical Study Site
Tampa, Florida, United States
NGM Clinical Study Site
Grand Rapids, Michigan, United States
NGM Clinical Study Site
New York, New York, United States
NGM Clinical Study Site
Oklahoma City, Oklahoma, United States
NGM Clinical Study Site
Austin, Texas, United States
NGM Clinical Study Site
Houston, Texas, United States
Number of Patients with Dose-limiting Toxicities
A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0 and is considered by the Investigator to be clinically relevant and attributed to the study treatment during the first 21 days after the first dose of study treatment.
Time frame: Baseline up to 21 Days
Incidence of Adverse Events
Number of patients with treatment-emergent adverse events (AEs) An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of patients who experience at least one AE will be presented.
Time frame: Baseline up to Approximately 24 months
Maximum Observed Serum Concentration (Cmax) of NGM831
Cmax is defined as the observed maximum serum concentration post drug administration. Will be measured for Cycle 1 and Cycle 3.
Time frame: Baseline up to approximately 9 weeks
Time to Maximum Observed Serum Concentration (Tmax) of NGM831
Tmax is defined as the time to reach the observed maximum serum concentration (Cmax) post drug administration. Will be measured for Cycle 1 and Cycle 3.
Time frame: Baseline up to approximately 9 weeks
Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831
AUC is defined as area under the concentration time curve of the dosing interval post drug administration. Will be calculated for Cycle 1 and Cycle 3.
Time frame: Baseline up to approximately 9 weeks
Maximum Observed Serum Concentration (Cmax) of NGM438
Cmax is defined as the observed maximum serum concentration post drug administration.Will be measured for Cycle 1 and Cycle 3.
Time frame: Baseline up to approximately 9 weeks
Time to Maximum Observed Serum Concentration (Tmax) of NGM438.
Tmax is defined as the time to reach the observed maximum serum concentration (Cmax) post drug administration. Will be measured for Cycle 1 and Cycle 3.
Time frame: Baseline up to approximately 9 weeks
Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438
AUC is defined as area under the concentration time curve of the dosing interval post drug administration. Will be calculated for Cycle 1 and Cycle 3.
Time frame: Baseline up to approximately 9 weeks
Anti-drug Antibodies (ADA) Against NGM831
Incidence and titers of anti-drug antibodies (ADA) against NGM831. Will be measured on Day 1 of each cycle.
Time frame: Baseline up to approximately 24 months
Anti-drug Antibodies (ADA) Against NGM438
Incidence and titers of anti-drug antibodies (ADA) against NGM438. Will be measured on Day 1 of each cycle.
Time frame: Baseline up to approximately 24 months
Neutralizing antibodies (nAb) against NGM831
Incidence and titers of neutralizing antibodies (nAb) against NGM831. Will be measured on Day 1 of each cycle.
Time frame: Baseline up to approximately 24 months
Neutralizing antibodies (nAb) against NGM438
Incidence and titers of neutralizing antibodies (nAb) against NGM438. Will be measured on Day 1 of each cycle.
Time frame: Baseline up to approximately 24 months
Number of Patients with Objective Responses
Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) divided by the total number of evaluable patients per RECIST v1.1.
Time frame: Baseline up to approximately 24 months
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