Clinical trial NCT05311618: Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors
Official title: A Phase 1/1b Dose Escalation/Expansion Study of NGM438 as Monotherapy and in Combination With Pembrolizumab 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 Cancer
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: 2022-04-05
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
* Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type for which the patient was eligible and willing to receive.
* 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 LAIR1

Primary outcomes:
measure: Number of Patients with Dose-limiting Toxicities
timeFrame: Baseline up to 21 Days
measure: Number of Patients with Adverse Events
timeFrame: Approximately 24 months
measure: Number of Patients with Clinically Significant Laboratory Abnormalities
timeFrame: Approximately 24 months
measure: Changes in potential pharmacodynamic biomarker CD163 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in CD163
timeFrame: Baseline up to 15 days
measure: Changes in potential pharmacodynamic biomarker MMP9 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in MMP9
timeFrame: Baseline up to 15 days
measure: Changes in potential pharmacodynamic biomarker CD8 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in CD8
timeFrame: Baseline up to 15 days
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of NGM438
timeFrame: Approximately 24 months. Each Cycle is 21 days.
measure: Area Under the Curve (AUC) of Serum NGM438
timeFrame: Approximately 24 months. Each Cycle is 21 days.
measure: Time to Maximum (Tmax) Observed Serum Concentration of NGM438
timeFrame: Approximately 24 months. Each Cycle is 21 days.
measure: Half-life (t1/2) of NGM438 in Serum
timeFrame: Approximately 24 months. Each Cycle is 21 days.
measure: Systemic Clearance (CL) of NGM438
timeFrame: Approximately 24 months. Each Cycle is 21 days.
measure: Volume of Distribution (Vss) of NGM438 at Steady State
timeFrame: Approximately 24 months. Each Cycle is 21 days.
measure: Anti-drug Antibodies (ADA) Against NGM438
timeFrame: Approximately 24 months. Each Cycle is 21 days.
measure: Number of Patients in Dose Escalation and Dose Finding Cohorts with Objective Responses
timeFrame: Approximately 24 months
measure: Trough Concentrations of NGM438 in Patients in the Biopsy Cohort
timeFrame: Approximately 24 months. Each Cycle is 21 days.
Other outcomes:
Locations:
city: Denver
country: United States
facility: SCRI Denver
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
References: