Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
A Phase 1 Dose Escalation/Dose Finding Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
2 other identifiers
interventional
130
1 country
9
Brief Summary
Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 pancreatic-cancer
Started Mar 2022
Typical duration for phase_1 pancreatic-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2022
CompletedFirst Posted
Study publicly available on registry
January 31, 2022
CompletedStudy Start
First participant enrolled
March 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedOctober 10, 2024
October 1, 2024
3.3 years
January 19, 2022
October 8, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Baseline up to Approximately 24 months
Secondary Outcomes (11)
Maximum Observed Serum Concentration (Cmax) of NGM831
Baseline up to approximately 9 weeks
Time to Maximum Observed Serum Concentration (Tmax) of NGM831
Baseline up to approximately 9 weeks
Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831
Baseline up to approximately 9 weeks
Maximum Observed Serum Concentration (Cmax) of NGM438
Baseline up to approximately 9 weeks
Time to Maximum Observed Serum Concentration (Tmax) of NGM438.
Baseline up to approximately 9 weeks
- +6 more secondary outcomes
Study Arms (3)
NGM831 Monotherapy Dose Escalation
EXPERIMENTALPart 1a Single Agent Dose Escalation
NGM831 combination dose finding with pembrolizumab (KEYTRUDA®)
EXPERIMENTALPart 1b NGM831 plus pembrolizumab (KEYTRUDA®)
NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®)
EXPERIMENTALPart 1c NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
- Adequate bone marrow, kidney and liver function
- Performance status of 0 or 1.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for AEs not constituting a safety risk by Investigator judgement.
You may not qualify if:
- Prior treatment targeting ILT3.
- Prior treatment targeting LAIR1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NGM Biopharmaceuticals, Inclead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (9)
NGM Clinical Study Site
Gilbert, Arizona, 85234, United States
NGM Clinical Study Site
Los Angeles, California, 90025, United States
NGM Clinical Study Site
Sarasota, Florida, 34232, United States
NGM Clinical Study Site
Tampa, Florida, 33612, United States
NGM Clinical Study Site
Grand Rapids, Michigan, 49546, United States
NGM Clinical Study Site
New York, New York, 10016, United States
NGM Clinical Study Site
Oklahoma City, Oklahoma, 73104, United States
NGM Clinical Study Site
Austin, Texas, 78758, United States
NGM Clinical Study Site
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2022
First Posted
January 31, 2022
Study Start
March 31, 2022
Primary Completion
July 1, 2025
Study Completion
March 1, 2026
Last Updated
October 10, 2024
Record last verified: 2024-10