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Brief Title: Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy

A Phase 1/2 Dose-Finding Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy

INTRODUCTION

  • Org Study ID: 18-0402
  • Secondary ID: N/A
  • NTC ID: NCT04068896
  • Sponsor: NGM Biopharmaceuticals, Inc

BRIEF SUMMARY

Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer.

  • Overall Status
    Recruiting
  • Start Date
    October 16, 2019
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)

Primary Outcome 1 - Timeframe: 19 weeks

CONDITION

  • Pancreatic Cancer
  • Metastatic Castration-resistant Prostate Cancer
  • Bladder Cancer
  • Melanoma
  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • Ovarian Cancer
  • Head Neck Squamous Cell Carcinoma

ELIGIBILITY

Inclusion Criteria:
Have histologically confirmed advanced or metastatic castration-resistant prostate cancer, bladder cancer, melanoma, non-small cell lung cancer, pancreatic cancer, colorectal cancer, gastric cancer, esophageal cancer, ovarian cancer, and head neck squamous cell carcinoma.
Or,
Have histologically confirmed metastatic pancreatic adenocarcinoma. Recurrent unresectable pancreatic cancer is acceptable as long as the treatment is first-line.
Have not received any approved chemotherapy, except in the adjuvant setting.
Exclusion Criteria:
Subject was using immunosuppressive medications within 14 days before Screening with the exception of topical (intranasal, inhaled, and local injection), systemic (prednisone equivalent 10 mg/day or less), or as needed for hypersensitivity reactions such as computed tomography (CT) scan premedication.

- Subject has active infections or other serious underlying significant medical illness, abnormal and clinically significant laboratory findings or psychiatric illness/social situation.

- Subject is using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants, cochlear implants, or other electronic medical equipment.

- Subject has documented immunodeficiency or organ transplant.

- Subject has an untreated central nervous system disease, leptomeningeal disease or cord compression.

- Subject has a history, or presence, of significant cardiovascular diseases; including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months before randomization, congestive heart failure > New York Heart Association Class II, severe peripheral vascular disease, corrected QT (QTc) prolongation >470 msec, clinically significant pericardial effusion.

- Subject has a history or presence of documented inflammatory bowel disease.
Subject is known to be positive for human immunodeficiency virus infection.
-

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: NGM Study Director

Role: Study Director

Affiliation: NGM Biopharmaceuticals, Inc

Overall Contact

Name: NGM Study Director

Phone: 650-243-5555

Email: ngm120@ngmbio.com

LOCATION

Facility Status Contact
Facility: NGM Clinical Study Site
Los Angeles, California 90048
United States
Status: Recruiting Contact: Contact
NGM Site 122

Facility: NGM Clinical Study Site
Los Angeles, California 90084
United States
Status: Recruiting Contact: Contact
NGM Site 105

Facility: NGM Clinical Study Site
Sacramento, California 98517
United States
Status: Recruiting Contact: Contact
NGM Site 108

Facility: NGM Clinical Study Site
San Diego, California 92123
United States
Status: Recruiting Contact: Contact
NGM Site 113

Facility: NGM Clinical Study Site
Santa Monica, California 90404
United States
Status: Recruiting Contact: Contact
NGM Site 102

Facility: NGM Clinical Study Site
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
NGM Site 110

Facility: NGM Clinical Study Site
Washington, District of Columbia 20007
United States
Status: Recruiting Contact: Contact
NGM Site 117

Facility: NGM Clinical Study Site
Miami, Florida 33136
United States
Status: Recruiting Contact: Contact
NGM Site 120

Facility: NGM Clinical Study Site
Chicago, Illinois 60611
United States
Status: Recruiting Contact: Contact
NGM Site 119

Facility: NGM Clinical Study Site
Lewiston, Maine 04240
United States
Status: Recruiting Contact: Contact
NGM Site 106

Facility: NGM Clinical Study Site
Baltimore, Maryland 21201
United States
Status: Recruiting Contact: Contact
NGM Site 103

Facility: NGM Clinical Study Site
Boston, Massachusetts 02118
United States
Status: Recruiting Contact: Contact
NGM Site 115

Facility: NGM Clinical Study Site
Detroit, Michigan 48201
United States
Status: Recruiting Contact: Contact
NGM Site 111

Facility: NGM Clinical Study Site
Lake Success, New York 11042
United States
Status: Recruiting Contact: Contact
NGM Site 123

Facility: NGM Clinical Study Site
Cincinnati, Ohio 45219
United States
Status: Recruiting Contact: Contact
NGM Site 104

Facility: NGM Clinical Study Site
Portland, Oregon 97239
United States
Status: Recruiting Contact: Contact
NGM Site 125

Facility: NGM Clinical Study Site
Philadelphia, Pennsylvania 19111
United States
Status: Recruiting Contact: Contact
NGM Site 124

Facility: NGM Clinical Study Site
Charleston, South Carolina 29425
United States
Status: Recruiting Contact: Contact
NGM Site 101

Facility: NGM Clinical Study Site
Greenville, South Carolina 29605
United States
Status: Recruiting Contact: Contact
NGM Site 116

Facility: NGM Clinical Study Site
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
NGM Site 118

Facility: NGM Clinical Study Site
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
NGM Site 127

Facility: NGM Clinical Study Site
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
NGM Site 107

Facility: NGM Clinical Study Site
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
NGM Site 126

Facility: NGM Clinical Study Site
Seattle, Washington 98101
United States
Status: Recruiting Contact: Contact
NGM Site 109

Facility: NGM Clinical Study Site
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: Contact
NGM Site 112