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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068896
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

Study Description
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Brief Summary:
Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer.

Condition or disease Intervention/treatment Phase
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 Biological: NGM120 Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1a/b Dose-Escalation 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
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NGM120 Dose 1
NGM120 Subcutaneous Injection
 Biological: NGM120
NGM120 Dose 1
Experimental: NGM120 Dose 2
NGM120 Subcutaneous Injection
 Biological: NGM120
NGM120 Dose 2
Experimental: NGM120 Dose 3
NGM120 Subcutaneous Injection
 Biological: NGM120
NGM120 Dose 3
Experimental: NGM120 Dose 4
NGM120 Subcutaneous Injection
 Biological: NGM120
NGM120 Dose 4
Experimental: NGM120 Dose 5
NGM120 Subcutaneous Injection
 Biological: NGM120
NGM120 Dose 5
Experimental: NGM120 Dose 6
NGM120 Subcutaneous Injection
 Biological: NGM120
NGM120 Dose 6
Placebo Comparator: Placebo
Placebo
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 19 weeks ]
    The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.


Secondary Outcome Measures :
  1. Serum Concentration of NGM120 [ Time Frame: 19 weeks ]
    NGM120 concentration data by cohort.

  2. Assessment of Anticancer Activity [ Time Frame: 19 weeks ]
    Assessed using the RECIST Version 1.1 criteria


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.

  2. Have not received any approved chemotherapy, except in the adjuvant setting.

Exclusion Criteria:

  1. 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.
  2. Subject has active infections or other serious underlying significant medical illness, abnormal and clinically significant laboratory findings or psychiatric illness/social situation.
  3. Subject is using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants, cochlear implants, or other electronic medical equipment.
  4. Subject has documented immunodeficiency or organ transplant.
  5. Subject has an untreated central nervous system disease, leptomeningeal disease or cord compression.
  6. 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.
  7. Subject has a history or presence of documented inflammatory bowel disease.

  8. Subject is known to be positive for human immunodeficiency virus infection.

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068896


Contacts
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Contact: Rosa Paz 650-243-5555 rpaz@ngmbio.com
Contact: Cecilia Tran-Muchowski 650-243-5555 ctranmuchowski@ngmbio.com

Locations
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United States, California
NGM Clinical Study Site Not yet recruiting
Los Angeles, California, United States, 90048
Contact: NGM Site 122         
NGM Clinical Study Site Recruiting
Los Angeles, California, United States, 90084
Contact: NGM Site 105         
NGM Clinical Study Site Recruiting
Sacramento, California, United States, 98517
Contact: NGM Site 108         
NGM Clinical Study Site Not yet recruiting
San Diego, California, United States, 92123
Contact: NGM Site 113         
NGM Clinical Study Site Not yet recruiting
Santa Monica, California, United States, 90404
Contact: NGM Site 102         
United States, Colorado
NGM Clinical Study Site Recruiting
Aurora, Colorado, United States, 80045
Contact: NGM Site 110         
United States, District of Columbia
NGM Clinical Study Site Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: NGM Site 117         
United States, Florida
NGM Clinical Study Site Not yet recruiting
Miami, Florida, United States, 33136
Contact: NGM Site 120         
United States, Illinois
NGM Clinical Study Site Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: NGM Site 119         
United States, Maine
NGM Clinical Study Site Recruiting
Lewiston, Maine, United States, 04240
Contact: NGM Site 106         
United States, Maryland
NGM Clinical Study Site Recruiting
Baltimore, Maryland, United States, 21201
Contact: NGM Site 103         
United States, Massachusetts
NGM Clinical Study Site Recruiting
Boston, Massachusetts, United States, 02118
Contact: NGM Site 115         
United States, Michigan
NGM Clinical Study Site Recruiting
Detroit, Michigan, United States, 48201
Contact: NGM Site 111         
United States, New York
NGM Clinical Study Site Not yet recruiting
Lake Success, New York, United States, 11042
Contact: NGM Site 123         
United States, Ohio
NGM Clinical Study Site Recruiting
Cincinnati, Ohio, United States, 45219
Contact: NGM Site 104         
United States, Oregon
NGM Clinical Study Site Not yet recruiting
Portland, Oregon, United States, 97239
Contact: NGM Site 125         
United States, Pennsylvania
NGM Clinical Study Site Not yet recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: NGM Site 124         
United States, South Carolina
NGM Clinical Study Site Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: NGM Site 101         
NGM Clinical Study Site Recruiting
Greenville, South Carolina, United States, 29605
Contact: NGM Site 116         
United States, Tennessee
NGM Clinical Study Site Recruiting
Nashville, Tennessee, United States, 37203
Contact: NGM Site 118         
United States, Texas
NGM Clinical Study Site Not yet recruiting
Dallas, Texas, United States, 75390
Contact: NGM Site 127         
NGM Clinical Study Site Not yet recruiting
Houston, Texas, United States, 77030
Contact: NGM Site 107         
NGM Clinical Study Site Not yet recruiting
Houston, Texas, United States, 77030
Contact: NGM Site 126         
United States, Washington
NGM Clinical Study Site Not yet recruiting
Seattle, Washington, United States, 98101
Contact: NGM Site 109         
United States, Wisconsin
NGM Clinical Study Site Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: NGM Site 112         
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
Investigators
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Study Director: NGM Study Director NGM Biopharmaceuticals, Inc
More Information
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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT04068896    
Other Study ID Numbers: 18-0402
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
 Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases