Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy
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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 30, 2022
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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 |
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 |
- 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.
- Incidence of Adverse Events [ Time Frame: 12 weeks ]Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug
- 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.
- Pharmacokinetics (PK) of NGM120 [ Time Frame: 19 weeks ]Pharmacokinetics (PK) of NGM120 by measuring serum concentration of NGM120 at specified timepoints
- Immunogenicity against NGM120 [ Time Frame: 19 weeks ]Immunogenicity against NGM120 by measuring percentage of subjects to develop antidrug antibodies and neutralizing antibodies
- 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
- Body weight during therapy with NGM120 [ Time Frame: 19 weeks ]Body weight during therapy with NGM120 by measuring change in body weight (in lb).
- 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.

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Part 1 and 2):
- 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.
- Life expectancy of at least 12 weeks
- 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.
- 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):
- Metastatic, castrate resistance, histologically confirmed prostate cancer; continuous medical castration for ≥8 weeks prior to screening.
- Effective castration with serum testosterone levels <0.5 ng/mL (50 ng/dL; 1.7 nmol/L).
- Have serum GDF15 levels ≥1300 pg/mL.
- 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.
- Have had PSA doubling time of >3 months.
Exclusion Criteria (All parts):
- 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 (HIV) infection.

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
Contact: NGM Study Director | 650-243-5555 | ngm120@ngmbio.com |
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 | Completed |
Sacramento, California, United States, 98517 | |
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 | Completed |
Miami, Florida, United States, 33136 | |
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 | Withdrawn |
Lake Success, New York, United States, 11042 | |
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 | Completed |
Cincinnati, Ohio, United States, 45219 | |
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 | Withdrawn |
Greenville, South Carolina, United States, 29605 | |
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 | Completed |
Milwaukee, Wisconsin, United States, 53226 |
Study Director: | NGM Study Director | NGM Biopharmaceuticals, Inc |
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 30, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |