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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 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
Tucson, Arizona 85719
United States
Status: Recruiting Contact: Contact
NGM Site 129

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
Baltimore, Maryland 21201
United States
Status: Recruiting Contact: Contact
NGM Site 123

Facility: NGM Clinical Study Site
Lake Success, New York 11042
United States
Status: Recruiting Contact: Contact
NGM Site 124

Facility: NGM Clinical Study Site
Cincinnati, Ohio 45219
United States
Status: Recruiting Contact: Contact
NGM Site 116

Facility: NGM Clinical Study Site
Philadelphia, Pennsylvania 19111
United States
Status: Recruiting Contact: Contact
NGM Site 127

Facility: NGM Clinical Study Site
Charleston, South Carolina 29425
United States
Status: Recruiting Contact: Contact
NGM Site 107

Facility: NGM Clinical Study Site
Greenville, South Carolina 29605
United States
Status: Recruiting Contact: Contact
NGM Site 126

Facility: NGM Clinical Study Site
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
NGM Site 109

Facility: NGM Clinical Study Site
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
NGM Site 112

Facility: NGM Clinical Study Site
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: NGM Clinical Study Site
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: NGM Clinical Study Site
Seattle, Washington 98101
United States
Status: Recruiting Contact: N/A
Facility: NGM Clinical Study Site
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: N/A