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

Phase 1

Active, not recruiting

• Conditions: Endocervical Cancer; Renal Cell Carcinoma; Mesothelioma; Cholangiocarcinoma; Breast Cancer; Gastric Cancer; Cervical Cancer; Squamous Cell Carcinoma of Head and Neck; Bladder Urothelial Cancer; Colorectal Carcinoma
• Interventions: Drug: NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®); Drug: NGM831; Drug: NGM831 plus pembrolizumab (KEYTRUDA®)

• Registration Number: NCT05215574
• Lead Sponsor: NGM Biopharmaceuticals, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-31
• Study Start: 2022-03-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-07
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®)	NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)	Part 1c NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)
NGM831 Monotherapy Dose Escalation	NGM831	Part 1a Single Agent Dose Escalation
NGM831 combination dose finding with pembrolizumab (KEYTRUDA®)	NGM831 plus pembrolizumab (KEYTRUDA®)	Part 1b NGM831 plus pembrolizumab (KEYTRUDA®)

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NGM Clinical Study Site; 🇺🇸 Houston, Texas, United States