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Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

NCT05215574•NGM Biopharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (9)

NGM Clinical Study Site

Gilbert, Arizona, United States

NGM Clinical Study Site

Los Angeles, California, United States

NGM Clinical Study Site

Sarasota, Florida, United States

NGM Clinical Study Site

Tampa, Florida, United States

NGM Clinical Study Site

Grand Rapids, Michigan, United States

NGM Clinical Study Site

New York, New York, United States

NGM Clinical Study Site

Oklahoma City, Oklahoma, United States

NGM Clinical Study Site

Austin, Texas, United States

NGM Clinical Study Site

Houston, Texas, United States

Key Dates

Start Date

March 31, 2022

Primary Completion Date

July 1, 2025

Completion Date

March 1, 2026

Last Updated

October 10, 2024

Enrollment

130

ESTIMATED participants

Conditions

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

Interventions

NGM831

DRUG

NGM831 plus pembrolizumab (KEYTRUDA®)

DRUG

NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)

DRUG

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

NCT05245812

Breast CancerHigh Risk of Breast Cancer

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RECRUITINGPHASE1

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

NCT05673200

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations