Clinical trial NCT05215574: Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: 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
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-01-31
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients with Dose-limiting Toxicities
timeFrame: Baseline up to 21 Days
measure: Incidence of Adverse Events
timeFrame: Baseline up to Approximately 24 months
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of NGM831
timeFrame: Baseline up to approximately 9 weeks
measure: Time to Maximum Observed Serum Concentration (Tmax) of NGM831
timeFrame: Baseline up to approximately 9 weeks
measure: Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831
timeFrame: Baseline up to approximately 9 weeks
measure: Maximum Observed Serum Concentration (Cmax) of NGM438
timeFrame: Baseline up to approximately 9 weeks
measure: Time to Maximum Observed Serum Concentration (Tmax) of NGM438.
timeFrame: Baseline up to approximately 9 weeks
measure: Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438
timeFrame: Baseline up to approximately 9 weeks
measure: Anti-drug Antibodies (ADA) Against NGM831
timeFrame: Baseline up to approximately 24 months
measure: Anti-drug Antibodies (ADA) Against NGM438
timeFrame: Baseline up to approximately 24 months
measure: Neutralizing antibodies (nAb) against NGM831
timeFrame: Baseline up to approximately 24 months
measure: Neutralizing antibodies (nAb) against NGM438
timeFrame: Baseline up to approximately 24 months
measure: Number of Patients with Objective Responses
timeFrame: Baseline up to approximately 24 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: NGM Clinical Study Site
state: Arizona
city: Los Angeles
country: United States
facility: NGM Clinical Study Site
state: California
city: Sarasota
country: United States
facility: NGM Clinical Study Site
state: Florida
city: Tampa
country: United States
facility: NGM Clinical Study Site
state: Florida
city: Grand Rapids
country: United States
facility: NGM Clinical Study Site
state: Michigan
city: New York
country: United States
facility: NGM Clinical Study Site
state: New York
city: Oklahoma City
country: United States
facility: NGM Clinical Study Site
state: Oklahoma
city: Austin
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Houston
country: United States
facility: NGM Clinical Study Site
state: Texas
Study officials:
References: