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

October 8, 2024 updated by: NGM Biopharmaceuticals, Inc

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • NGM Clinical Study Site
    • California
      • Los Angeles, California, United States, 90025
        • NGM Clinical Study Site
    • Florida
      • Sarasota, Florida, United States, 34232
        • NGM Clinical Study Site
      • Tampa, Florida, United States, 33612
        • NGM Clinical Study Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • NGM Clinical Study Site
    • New York
      • New York, New York, United States, 10016
        • NGM Clinical Study Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • NGM Clinical Study Site
    • Texas
      • Austin, Texas, United States, 78758
        • NGM Clinical Study Site
      • Houston, Texas, United States, 77030
        • NGM Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NGM831 Monotherapy Dose Escalation
Part 1a Single Agent Dose Escalation
Drug: NGM831
Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
Experimental: NGM831 combination dose finding with pembrolizumab (KEYTRUDA®)
Part 1b NGM831 plus pembrolizumab (KEYTRUDA®)
Drug: 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.
Experimental: NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®)
Part 1c NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients with Dose-limiting Toxicities
Time Frame: 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.
Baseline up to 21 Days
Incidence of Adverse Events
Time Frame: 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.
Baseline up to Approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Serum Concentration (Cmax) of NGM831
Time Frame: Baseline up to approximately 9 weeks

Cmax is defined as the observed maximum serum concentration post drug administration.

Will be measured for Cycle 1 and Cycle 3.
Baseline up to approximately 9 weeks
Time to Maximum Observed Serum Concentration (Tmax) of NGM831
Time Frame: Baseline up to approximately 9 weeks

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.
Baseline up to approximately 9 weeks
Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831
Time Frame: Baseline up to approximately 9 weeks

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.
Baseline up to approximately 9 weeks
Maximum Observed Serum Concentration (Cmax) of NGM438
Time Frame: Baseline up to approximately 9 weeks
Cmax is defined as the observed maximum serum concentration post drug administration.Will be measured for Cycle 1 and Cycle 3.
Baseline up to approximately 9 weeks
Time to Maximum Observed Serum Concentration (Tmax) of NGM438.
Time Frame: Baseline up to approximately 9 weeks

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.
Baseline up to approximately 9 weeks
Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438
Time Frame: Baseline up to approximately 9 weeks

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.
Baseline up to approximately 9 weeks
Anti-drug Antibodies (ADA) Against NGM831
Time Frame: Baseline up to approximately 24 months
Incidence and titers of anti-drug antibodies (ADA) against NGM831. Will be measured on Day 1 of each cycle.
Baseline up to approximately 24 months
Anti-drug Antibodies (ADA) Against NGM438
Time Frame: Baseline up to approximately 24 months
Incidence and titers of anti-drug antibodies (ADA) against NGM438. Will be measured on Day 1 of each cycle.
Baseline up to approximately 24 months
Neutralizing antibodies (nAb) against NGM831
Time Frame: Baseline up to approximately 24 months
Incidence and titers of neutralizing antibodies (nAb) against NGM831. Will be measured on Day 1 of each cycle.
Baseline up to approximately 24 months
Neutralizing antibodies (nAb) against NGM438
Time Frame: Baseline up to approximately 24 months
Incidence and titers of neutralizing antibodies (nAb) against NGM438. Will be measured on Day 1 of each cycle.
Baseline up to approximately 24 months
Number of Patients with Objective Responses
Time Frame: Baseline up to approximately 24 months
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.
Baseline up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NGM Biopharmaceuticals, Inc

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

January 19, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 831-IO-101
  • KEYNOTE-E13 (Other Identifier: MK-3475-E13 Merck Sharp & Dohme LLC.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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