Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy
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
1 other identifier
interventional
89
1 country
20
Brief Summary
Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 pancreatic-cancer
Started Oct 2019
Typical duration for phase_1 pancreatic-cancer
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedStudy Start
First participant enrolled
October 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2024
CompletedResults Posted
Study results publicly available
May 29, 2025
CompletedMay 29, 2025
March 1, 2025
3.9 years
August 22, 2019
March 4, 2025
May 23, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
To Determine the Safety and Tolerability of NGM120 in Subjects
Number of Participants with NGM120/Placebo-Related Treatment Emergent Adverse Events
From enrollment to end of treatment up to 24 months
To Determine the Safety and Tolerability of NGM120
Discontinuation of investigational product due to toxicity
From enrollment to end of treatment up to 24 months
To Determine the Safety and Tolerability of NGM120
Local injection-site symptom assessment as evidenced by incidence of injection-site reactions
From enrollment to end of treatment up to 24 months
Study Arms (6)
Part 1 NGM120 30mg
EXPERIMENTALNGM120 30mg Subcutaneous Injection
Part 1 NGM120 100mg
EXPERIMENTALNGM120 100mg Subcutaneous Injection
Part 2 NGM120 30mg
EXPERIMENTALNGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
Part 2 NGM120 100mg
EXPERIMENTALNGM120 100mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
Part 3 NGM120 100mg Q3W
EXPERIMENTALNGM120 100mg Subcutaneous Injection NGM120 100mg Subcutaneous Injection every 3 weeks
Part 2 Placebo
PLACEBO COMPARATORPlacebo together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
Interventions
NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
NGM120 100 mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
NGM Clinical Study Site
Tucson, Arizona, 85719, United States
NGM Clinical Study Site
Los Angeles, California, 90048, United States
NGM Clinical Study Site
Los Angeles, California, 90084, United States
NGM Clinical Study Site
Sacramento, California, 98517, United States
NGM Clinical Study Site
San Diego, California, 92123, United States
NGM Clinical Study Site
Santa Monica, California, 90404, United States
NGM Clinical Study Site
Aurora, Colorado, 80045, United States
NGM Clinical Study Site
Washington D.C., District of Columbia, 20007, United States
NGM Clinical Study Site
Miami, Florida, 33136, United States
NGM Clinical Study Site
Chicago, Illinois, 60611, United States
NGM Clinical Study Site
Baltimore, Maryland, 21201, United States
NGM Clinical Study Site
Cincinnati, Ohio, 45219, United States
NGM Clinical Study Site
Philadelphia, Pennsylvania, 19111, United States
NGM Clinical Study Site
Charleston, South Carolina, 29425, United States
NGM Clinical Study Site
Myrtle Beach, South Carolina, 29572, United States
NGM Clinical Study Site
Nashville, Tennessee, 37203, United States
NGM Clinical Study Site
Dallas, Texas, 75390, United States
NGM Clinical Study Site
Houston, Texas, 77030, United States
NGM Clinical Study Site
Seattle, Washington, 98101, United States
NGM Clinical Study Site
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP Clinical Operations
- Organization
- NGM Biopharmaceuticals
Study Officials
- STUDY DIRECTOR
NGM Study Director
NGM Biopharmaceuticals, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2019
First Posted
August 28, 2019
Study Start
October 16, 2019
Primary Completion
September 21, 2023
Study Completion
January 8, 2024
Last Updated
May 29, 2025
Results First Posted
May 29, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share