Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors
A Phase 1/1b Dose Escalation/Expansion Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors
3 other identifiers
interventional
71
1 country
6
Brief Summary
Study of NGM438 as Monotherapy and in Combination with Pembrolizumab 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 May 2022
6 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
March 18, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedStudy Start
First participant enrolled
May 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedApril 1, 2024
March 1, 2024
2.9 years
March 18, 2022
March 28, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
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
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.
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.
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
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
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
Baseline up to 15 days
Secondary Outcomes (9)
Maximum Observed Serum Concentration (Cmax) of NGM438
Approximately 24 months. Each Cycle is 21 days.
Area Under the Curve (AUC) of Serum NGM438
Approximately 24 months. Each Cycle is 21 days.
Time to Maximum (Tmax) Observed Serum Concentration of NGM438
Approximately 24 months. Each Cycle is 21 days.
Half-life (t1/2) of NGM438 in Serum
Approximately 24 months. Each Cycle is 21 days.
Systemic Clearance (CL) of NGM438
Approximately 24 months. Each Cycle is 21 days.
- +4 more secondary outcomes
Study Arms (3)
NGM438 Monotherapy Dose Escalation
EXPERIMENTALPart 1a Single Agent Dose Escalation
NGM438 Combination Dose Finding with pembrolizumab ( KEYTRUDA ® )
EXPERIMENTALPart 1b NGM438 plus pembrolizumab ( KEYTRUDA ® )
Biopsy Cohort with NGM438 Monotherapy Followed by Combination Therapy with Pembrolizumab(KEYTRUDA ®)
EXPERIMENTALPart 1C NGM438 followed by NGM438 plus pembrolizumab ( KEYTRUDA ® )
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
- Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type for which the patient was eligible and willing to receive.
- 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 LAIR1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NGM Biopharmaceuticals, Inclead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (6)
SCRI Denver
Denver, Colorado, 80218, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
START Midwest
Grand Rapids, Michigan, 49546, United States
Mount Sinai Hospital
New York, New York, 10029, United States
MD Anderson
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
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2022
First Posted
April 5, 2022
Study Start
May 11, 2022
Primary Completion
April 1, 2025
Study Completion
June 1, 2025
Last Updated
April 1, 2024
Record last verified: 2024-03