Study Of NGM831 As Monotherapy And In Combination With Pembrolizumab Or Pembrolizumab And NGM438 In Advanced Or Metastatic Solid Tumors

Study Overview

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

N/A

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

DRUG: NGM831
DRUG: NGM831 plus pembrolizumab (KEYTRUDA®)
DRUG: NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)

831-IO-101
KEYNOTE-E13 (OTHER Identifier) (OTHER: MK-3475-E13 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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-01-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-10-08
First Submitted that Met QC Criteria 2022-01-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-10-10
First Posted (ACTUAL) 2022-01-31	Results First Posted N/A	Last Verified 2024-10

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

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: pembr

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: pembr

Primary Outcome Measures	Measure Description	Time Frame
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
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 Outcome Measures	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Prior treatment targeting ILT3.
Prior treatment targeting LAIR1.

Collaborators and Investigators

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

Merck Sharp & Dohme LLC

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record