Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy (PINNACLES)
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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 : March 2, 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 | 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
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Other: Placebo
Placebo |
- 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.
- Serum Concentration of NGM120 [ Time Frame: 19 weeks ]NGM120 concentration data by cohort.
- Assessment of Anticancer Activity [ Time Frame: 19 weeks ]Assessed using the RECIST Version 1.1 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 |
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.
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Subject is known to be positive for human immunodeficiency virus infection.
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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 | 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, 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 | |
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 |
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: | March 2, 2022 |
Last Verified: | May 2021 |
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 |
Pancreatic Neoplasms Neoplasms by Site Neoplasms Digestive System Neoplasms |
Digestive System Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |