Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors

NCT05215574 · tracked via the Priya Life Science USA tracker

Sponsor

NGM Biopharmaceuticals, Inc

Phase

Phase 1

Started

2022-03-31

Last updated

2024-10-10

Condition(s) studied

Pancreatic CancerBreast CancerGastric CancerNon-small Cell Lung CancerCervical CancerEndocervical CancerSquamous Cell Carcinoma of Head and NeckBladder Urothelial CancerColorectal CarcinomaEsophageal CancerOvarian CancerRenal Cell CarcinomaProstate CancerMelanomaMesotheliomaCholangiocarcinoma

Investigational drug(s) / intervention(s)

NGM831NGM831 plus pembrolizumab (KEYTRUDA®)NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)

NGM831: Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.

NGM831 plus pembrolizumab (KEYTRUDA®): 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.

NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®): 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.

Study summary

Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * Prior treatment targeting ILT3. * Prior treatment targeting LAIR1.

Primary outcome measure(s)

Number of Patients with Dose-limiting Toxicities — Baseline up to 21 Days
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.
Incidence of Adverse Events — Baseline up to Approximately 24 months
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.

Trial sites (9)

Facility	City	Region
NGM Clinical Study Site	Gilbert	Arizona
NGM Clinical Study Site	Los Angeles	California
NGM Clinical Study Site	Sarasota	Florida
NGM Clinical Study Site	Tampa	Florida
NGM Clinical Study Site	Grand Rapids	Michigan
NGM Clinical Study Site	New York	New York
NGM Clinical Study Site	Oklahoma City	Oklahoma
NGM Clinical Study Site	Austin	Texas
NGM Clinical Study Site	Houston	Texas

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05215574 on ClinicalTrials.gov ↗ ← All trials in the USA