A Phase 1 interventional study of NGM438 and Pembrolizumab (KEYTRUDA ®) in Pancreatic Cancer, Breast Cancer and Gastric Cancer, sponsored by NGM Biopharmaceuticals, Inc. Active, not recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by NGM Biopharmaceuticals, Inc · Phase 1, Interventional, and Treatment
Study of NGM438 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 71 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →NGM Biopharmaceuticals, Inc is the lead sponsor of 26 studies on the registry; 1 is open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Part 1a Single Agent Dose Escalation
Drug: NGM438
Part 1b NGM438 plus pembrolizumab ( KEYTRUDA ® )
Drug: NGM438 · Drug: Pembrolizumab (KEYTRUDA ®)
Part 1C NGM438 followed by NGM438 plus pembrolizumab ( KEYTRUDA ® )
Drug: NGM438 · Drug: Pembrolizumab (KEYTRUDA ®)
NGM438 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
Pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21 day cycle.
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
Number of Patients with Adverse Events
Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug. An AE is defined as any untoward medical occurrence in a patient, 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: Approximately 24 months
Number of Patients with Clinically Significant Laboratory Abnormalities
Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing.
Time frame: Approximately 24 months
Changes in potential pharmacodynamic biomarker CD163 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in CD163
Time frame: Baseline up to 15 days
Changes in potential pharmacodynamic biomarker MMP9 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in MMP9
Time frame: Baseline up to 15 days
Changes in potential pharmacodynamic biomarker CD8 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in CD8
Time frame: Baseline up to 15 days
Maximum Observed Serum Concentration (Cmax) of NGM438
Cmax is defined as the observed maximum serum concentration post drug administration. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycles 4-6 and every third cycle thereafter
Time frame: Approximately 24 months. Each Cycle is 21 days.
Area Under the Curve (AUC) of Serum NGM438
Area under the curve from time zero extrapolated to the last time point prior to the next dose. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycles 4-6 and every third cycle thereafter
Time frame: Approximately 24 months. Each Cycle is 21 days.
Time to Maximum (Tmax) Observed Serum Concentration of NGM438
Tmax is defined as the time to reach the observed maximum serum concentration (Cmax). Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycles 4-6 and every third cycle thereafter
Time frame: Approximately 24 months. Each Cycle is 21 days.
Half-life (t1/2) of NGM438 in Serum
Time measured for the serum concentration to decrease by one half during the terminal phase. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycles 4-6 and every third cycle thereafter
Time frame: Approximately 24 months. Each Cycle is 21 days.
Systemic Clearance (CL) of NGM438
CL is defined as systemic clearance. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycles 4-6 and every third cycle thereafter
Time frame: Approximately 24 months. Each Cycle is 21 days.
Volume of Distribution (Vss) of NGM438 at Steady State
Vss is defined as the volume of distribution at steady state. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycles 4-6 and every third cycle thereafter
Time frame: Approximately 24 months. Each Cycle is 21 days.
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 through Cycle 6 and every third cycle thereafter.
Time frame: Approximately 24 months. Each Cycle is 21 days.
Number of Patients in Dose Escalation and Dose Finding Cohorts 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: Approximately 24 months
Trough Concentrations of NGM438 in Patients in the Biopsy Cohort
Trough Concentration refers to the serum concentration of NGM438 observed just before treatment administration. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.
Time frame: Approximately 24 months. Each Cycle is 21 days.
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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NGM Biopharmaceuticals, Inc