Clinical trial NCT04913337: Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
Official title: A Phase 1/2 Dose Escalation/Expansion Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Mesothelioma
Glioblastoma
Renal Cell Carcinoma
Non Small Cell Lung Cancer
Melanoma
Pancreatic Ductal Adenocarcinoma
Gastric Cancer
Squamous Cell Carcinoma of Head and Neck
Cholangiocarcinoma
Breast Cancer
Ovarian Cancer
Cervical Cancer
Endocervical Cancer
Colorectal Cancer
Esophageal Cancer
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-06-04
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies


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, and for which the patient was eligible and willing to receive, or refused SOC treatments that are perceived to have marginal clinical benefit.
* 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 ILT2 and/or ILT4 or targeting HLA-G.

Primary outcomes:
measure: Number of Patients with Dose-limiting Toxicities
timeFrame: Baseline up to 28 Days
measure: Incidence of Adverse Events
timeFrame: Baseline up to Approximately 24 Months
measure: Number of Patients with Clinically Significant Laboratory Abnormalities
timeFrame: Baseline up to Approximately 24 Months
measure: Number of Patients in Expansion Cohorts with Objective Responses
timeFrame: Baseline up to approximately 24 months
measure: Duration of Response for Patients in Expansion Cohorts
timeFrame: Baseline up to approximately 24 months
measure: Progression-free Survival for Patients in Expansion Cohorts
timeFrame: Baseline up to approximately 24 months
measure: Overall Survival for Patients in Combination Dose Expansion Cohorts
timeFrame: Up to approximately 48 months
Secondary outcomes:
measure: Observed Plasma Concentration of NGM707 (Including Cmax)
timeFrame: Baseline up to approximately 24 months
measure: Area Under the Curve (AUC) of Plasma NGM707
timeFrame: Baseline up to approximately 24 months
measure: Plasma Half-life (t1/2) of NGM707
timeFrame: Baseline up to approximately 24 months
measure: Anti-drug Antibodies (ADA) Against NGM707
timeFrame: Baseline up to approximately 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: NGM Clinical Study Site
state: California
city: Newport Beach
country: United States
facility: NGM Clinical Study Site
state: California
city: Santa Monica'
country: United States
facility: NGM Clinical Study Site
state: California
city: Santa Rosa
country: United States
facility: NGM Clinical Study Site
state: California
city: Lone Tree
country: United States
facility: NGM Clinical Study Site
state: Colorado
city: Washington
country: United States
facility: NGM Clinical Study Site
state: District of Columbia
city: Sarasota
country: United States
facility: NGM Clinical Study Site
state: Florida
city: Baltimore
country: United States
facility: NGM Clinical Study Site
state: Maryland
city: Boston
country: United States
facility: NGM Clinical Study Site
state: Massachusetts
city: Grand Rapids
country: United States
facility: NGM Clinical Study Site
state: Michigan
city: Omaha
country: United States
facility: NGM Clinical Study Site
state: Nebraska
city: Albany
country: United States
facility: NGM Clinical Study Site
state: New York
city: Greenville
country: United States
facility: NGM Clinical Study Site
state: South Carolina
city: Dallas
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Houston
country: United States
facility: NGM Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: NGM Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Blacksburg
country: United States
facility: NGM Clinical Study Site
state: Virginia
city: Vancouver
country: United States
facility: NGM Clinical Study Site
state: Washington
city: Seoul
country: Korea, Republic of
facility: NGM Clinical Study Site
city: Seoul
country: Korea, Republic of
facility: NGM Clinical Study Site
city: Seoul
country: Korea, Republic of
facility: NGM Clinical Study Site
city: New Taipei City
country: Taiwan
facility: NGM Clinical Study Site
city: Taichung
country: Taiwan
facility: NGM Clinical Study Site
city: Tainan
country: Taiwan
facility: NGM Clinical Study Site
city: Taipei
country: Taiwan
facility: NGM Clinical Study Site
Study officials:
affiliation: NGM Biopharmaceuticals, Inc
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: