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History of Changes for Study: NCT04068896
Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy
Latest version (submitted August 8, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 23, 2019 None (earliest Version on record)
2 November 12, 2019 Recruitment Status, Contacts/Locations and Study Status
3 November 18, 2019 IPDSharing and Study Status
4 February 12, 2020 Study Status and Contacts/Locations
5 June 29, 2020 Contacts/Locations and Study Status
6 April 13, 2021 Contacts/Locations, Study Status and Study Identification
7 April 22, 2021 Study Status and Study Identification
8 May 20, 2021 Study Status and Study Design
9 February 25, 2022 Contacts/Locations, Study Status, Eligibility, Study Design and Study Identification
10 August 8, 2022 Outcome Measures, Study Status, Study Identification, Contacts/Locations, Eligibility, Conditions and Study Description
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Study NCT04068896
Submitted Date:  August 23, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 18-0402
Brief Title: Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2019
Overall Status: Not yet recruiting
Study Start: August 2019
Primary Completion: February 2021 [Anticipated]
Study Completion: December 2021 [Anticipated]
First Submitted: August 22, 2019
First Submitted that
Met QC Criteria:
August 23, 2019
First Posted: August 28, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
August 23, 2019
Last Update Posted: August 28, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: NGM Biopharmaceuticals, Inc
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer.
Detailed Description:
Open or close this module Conditions
Conditions: 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
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Number of Arms: 7
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 90 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Placebo
Placebo
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.

    -

Open or close this module Contacts/Locations
Central Contact Person: Kathy Kim
Telephone: 650-243-5555
Email: kkim@ngmbio.com
Central Contact Backup: Bryan Baxter
Telephone: 650-243-5555
Email: bbaxter@ngmbio.com
Study Officials: NGM Study Director
Study Director
NGM Biopharmaceuticals, Inc
Locations: United States, California
NGM Clinical Study Site
Los Angeles, California, United States, 90048
Contact:Contact: NGM Site 122
NGM Clinical Study Site
Los Angeles, California, United States, 90084
NGM Clinical Study Site
Sacramento, California, United States, 98517
Contact:Contact: NGM Site 108
NGM Clinical Study Site
San Diego, California, United States, 92123
Contact:Contact: NGM Site 113
NGM Clinical Study Site
Santa Monica, California, United States, 90404
Contact:Contact: NGM Site 102
United States, Colorado
NGM Clinical Study Site
Aurora, Colorado, United States, 80045
Contact:Contact: NGM Site 110
United States, District of Columbia
NGM Clinical Study Site
Washington, District of Columbia, United States, 20007
Contact:Contact: NGM Site 117
United States, Florida
NGM Clinical Study Site
Miami, Florida, United States, 33136
Contact:Contact: NGM Site 120
United States, Illinois
NGM Clinical Study Site
Chicago, Illinois, United States, 60611
Contact:Contact: NGM Site 119
United States, Maine
NGM Clinical Study Site
Lewiston, Maine, United States, 04240
Contact:Contact: NGM Site 106
United States, Maryland
NGM Clinical Study Site
Baltimore, Maryland, United States, 21201
Contact:Contact: NGM Site 103
United States, Massachusetts
NGM Clinical Study Site
Boston, Massachusetts, United States, 02118
Contact:Contact: NGM Site 115
NGM Clinical Study Site
Boston, Massachusetts, United States, 02218
Contact:Contact: NGM Site 114
United States, Michigan
NGM Clinical Study Site
Detroit, Michigan, United States, 48201
Contact:Contact: NGM Site 111
United States, New York
NGM Clinical Study Site
Lake Success, New York, United States, 11042
Contact:Contact: NGM Site 123
United States, Ohio
NGM Clinical Study Site
Cincinnati, Ohio, United States, 45219
Contact:Contact: NGM Site 104
United States, South Carolina
NGM Clinical Study Site
Charleston, South Carolina, United States, 29425
Contact:Contact: NGM Site 101
NGM Clinical Study Site
Greenville, South Carolina, United States, 29605
Contact:Contact: NGM Site 116
United States, Tennessee
NGM Clinical Study Site
Nashville, Tennessee, United States, 37203
Contact:Contact: NGM Site 118
United States, Texas
NGM Clinical Study Site
Houston, Texas, United States, 77030
Contact:Contact: NGM Site 107
United States, Washington
NGM Clinical Study Site
Seattle, Washington, United States, 98101
Contact:Contact: NGM Site 109
United States, Wisconsin
NGM Clinical Study Site
Milwaukee, Wisconsin, United States, 53226
Contact:Contact: NGM Site 112
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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