Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate 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 : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

Brief Summary:
Study of NGM120 in subjects with advanced solid tumors and and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3).

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 Prostate Cancer Biological: NGM120 Other: Placebo Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : January 2025


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




Primary Outcome Measures :
  1. Number of patients with Dose-Limiting Toxicities: [ Time Frame: 12 weeks ]
    A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0 and is considered by the investigator to be clinically relevant and attributed to the study treatment during the first 28 days after the first dose of study treatment.

  2. Incidence of Adverse Events [ Time Frame: 12 weeks ]
    Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug

  3. Number of Patients with Clinically Significant Laboratory Abnormalities: [ Time Frame: 12 weeks ]
    Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing.


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of NGM120 [ Time Frame: 19 weeks ]
    Pharmacokinetics (PK) of NGM120 by measuring serum concentration of NGM120 at specified timepoints

  2. Immunogenicity against NGM120 [ Time Frame: 19 weeks ]
    Immunogenicity against NGM120 by measuring percentage of subjects to develop antidrug antibodies and neutralizing antibodies

  3. Assessment of Antitumor and Anticachexia Activity Assessed using the RECIST Version 1.1 criteria [ Time Frame: 19 weeks ]
    Assessment of Antitumor and Anticachexia Activity Assessed using the RECIST Version 1.1 criteria

  4. Body weight during therapy with NGM120 [ Time Frame: 19 weeks ]
    Body weight during therapy with NGM120 by measuring change in body weight (in lb).

  5. Skeletal muscle index during therapy with NGM120 [ Time Frame: 19 weeks ]
    Skeletal muscle index during therapy with NGM120 by measuring skeletal muscle mass and adiposity at level of L3 on serial CT scan.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria (Part 1 and 2):

  1. 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.
  3. Life expectancy of at least 12 weeks
  4. Male subjects must agree to use contraception as per protocol during the treatment period and for at least 90 days after the last study treatment administration and refrain from donating sperm during this period.
  5. Provision of an archival tumor sample (within 5 years). If an archival sample is unavailable, a fresh biopsy can be obtained during Screening. If archival tissue or biopsy sample is unavailable, the subject is ineligible.

Inclusion Criteria (Part 3 Prostate Cancer):

  1. Metastatic, castrate resistance, histologically confirmed prostate cancer; continuous medical castration for ≥8 weeks prior to screening.
  2. Effective castration with serum testosterone levels <0.5 ng/mL (50 ng/dL; 1.7 nmol/L).
  3. Have serum GDF15 levels ≥1300 pg/mL.
  4. Have experienced PSA progression under 1 or more lines of ADT in the absence or presence of radiographic and/or clinical progression, who decline or are not eligible to receive chemotherapy.
  5. Have had PSA doubling time of >3 months.

Exclusion Criteria (All parts):

  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 (HIV) infection.

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
Layout table for location contacts
Contact: NGM Study Director 650-243-5555 ngm120@ngmbio.com

Locations
Layout table for location information
United States, Arizona
NGM Clinical Study Site Recruiting
Tucson, Arizona, United States, 85719
Contact: NGM Site 129         
United States, California
NGM Clinical Study Site 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 Recruiting
San Diego, California, United States, 92123
Contact: NGM Site 113         
NGM Clinical Study Site 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 Recruiting
Washington, District of Columbia, United States, 20007
Contact: NGM Site 117         
United States, Florida
NGM Clinical Study Site Recruiting
Miami, Florida, United States, 33136
Contact: NGM Site 120         
United States, Illinois
NGM Clinical Study Site Recruiting
Chicago, Illinois, United States, 60611
Contact: NGM Site 119         
United States, Maine
NGM Clinical Study Site Withdrawn
Lewiston, Maine, United States, 04240
United States, Maryland
NGM Clinical Study Site Recruiting
Baltimore, Maryland, United States, 21201
Contact: NGM Site 103         
United States, Massachusetts
NGM Clinical Study Site Withdrawn
Boston, Massachusetts, United States, 02118
United States, Michigan
NGM Clinical Study Site Withdrawn
Detroit, Michigan, United States, 48201
United States, Nebraska
NGM Clinical Study Site Recruiting
Omaha, Nebraska, United States, 68130
Contact: Site 132         
United States, New York
NGM Clinical Study Site Recruiting
Lake Success, New York, United States, 11042
Contact: NGM Site 123         
United States, North Carolina
NGM Clinical Study Site Not yet recruiting
Charlotte, North Carolina, United States, 28204
Contact: NGM Site 128         
United States, Ohio
NGM Clinical Study Site Recruiting
Cincinnati, Ohio, United States, 45219
Contact: NGM Site 104         
United States, Oregon
NGM Clinical Study Site Withdrawn
Portland, Oregon, United States, 97239
United States, Pennsylvania
NGM Clinical Study Site Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: NGM Site 124         
United States, South Carolina
NGM Clinical Study Site 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         
NGM Clinical Study Site Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: NGM Site 131         
United States, Tennessee
NGM Clinical Study Site Recruiting
Nashville, Tennessee, United States, 37203
Contact: NGM Site 118         
United States, Texas
NGM Clinical Study Site Recruiting
Dallas, Texas, United States, 75390
Contact: NGM Site 127         
NGM Clinical Study Site Recruiting
Houston, Texas, United States, 77030
Contact: NGM Site 107         
NGM Clinical Study Site Recruiting
Houston, Texas, United States, 77030
Contact: NGM Site 126         
NGM Clinical Study Site Withdrawn
San Antonio, Texas, United States, 78229
United States, Washington
NGM Clinical Study Site 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
Layout table for investigator information
Study Director: NGM Study Director NGM Biopharmaceuticals, Inc
Layout table for additonal information
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: August 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Pancreatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Digestive System Neoplasms
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases