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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05215574
• Other study ID #: 831-IO-101
• Secondary ID: KEYNOTE-E13
• Status: Recruiting
• Phase: Phase 1
• Start date: March 31, 2022
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: NGM Biopharmaceuticals, Inc
• Contact: NGM Medical Director
• Phone: (650) 243-5555
• Email: NGM831[@]ngmbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Urothelial Cancer
• Breast Cancer
• Carcinoma
• Cervical Cancer
• Cholangiocarcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms
• Esophageal Cancer
• Gastric Cancer
• Melanoma
• Mesothelioma
• Non-small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer
• Renal Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	NGM Clinical Study Site	Austin	Texas
United States	NGM Clinical Study Site	Gilbert	Arizona
United States	NGM Clinical Study Site	Grand Rapids	Michigan
United States	NGM Clinical Study Site	Houston	Texas
United States	NGM Clinical Study Site	Los Angeles	California
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	Sarasota	Florida
United States	NGM Clinical Study Site	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
NGM Biopharmaceuticals, Inc	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Maximum Observed Serum Concentration (Cmax) of NGM831	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
Secondary	Time to Maximum Observed Serum Concentration (Tmax) of NGM831	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
Secondary	Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831	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
Secondary	Maximum Observed Serum Concentration (Cmax) of NGM438	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
Secondary	Time to Maximum Observed Serum Concentration (Tmax) of NGM438.	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
Secondary	Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438	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
Secondary	Anti-drug Antibodies (ADA) Against NGM831	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
Secondary	Anti-drug Antibodies (ADA) Against NGM438	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
Secondary	Neutralizing antibodies (nAb) against NGM831	Incidence and titers of neutralizing antibodies (nAb) against NGM831. Will be measured on Day 1 of each cycle.	Baseline up to approximately 24 months
Secondary	Neutralizing antibodies (nAb) against NGM438	Incidence and titers of neutralizing antibodies (nAb) against NGM438. Will be measured on Day 1 of each cycle.	Baseline up to approximately 24 months
Secondary	Number of Patients with Objective Responses	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