Pancreatic CancerPhase 1/2NCT04068896

Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy

A Phase 1/2 study testing NGM120 30mg, NGM120 100mg and NGM120 30mg with Gemcitabine and Abraxane in people with Pancreatic Cancer and Metastatic Castration-resistant Prostate Cancer, run by NGM Biopharmaceuticals, Inc at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Cancer, Metastatic Castration-resistant Prostate Cancer, Bladder Cancer
What is being tested?: NGM120 30mg, NGM120 100mg and NGM120 30mg with Gemcitabine and Abraxane
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: 20 sitesUnited States
Study dates: 16 Oct 2019to 8 Jan 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

NGM Clinical Study Site
Aurora, Colorado, 80045
NGM Clinical Study Site
Baltimore, Maryland, 21201
NGM Clinical Study Site
Charleston, South Carolina, 29425
NGM Clinical Study Site
Chicago, Illinois, 60611
NGM Clinical Study Site
Cincinnati, Ohio, 45219
NGM Clinical Study Site
Dallas, Texas, 75390
NGM Clinical Study Site
Houston, Texas, 77030
NGM Clinical Study Site
Los Angeles, California, 90048
NGM Clinical Study Site
Los Angeles, California, 90084
NGM Clinical Study Site
Miami, Florida, 33136
NGM Clinical Study Site
Milwaukee, Wisconsin, 53226
NGM Clinical Study Site
Myrtle Beach, South Carolina, 29572
NGM Clinical Study Site
Nashville, Tennessee, 37203
NGM Clinical Study Site
Philadelphia, Pennsylvania, 19111
NGM Clinical Study Site
Sacramento, California, 98517
NGM Clinical Study Site
San Diego, California, 92123
NGM Clinical Study Site
Santa Monica, California, 90404
NGM Clinical Study Site
Seattle, Washington, 98101
NGM Clinical Study Site
Tucson, Arizona, 85719
NGM Clinical Study Site
Washington D.C., District of Columbia, 20007

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About this study

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

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

Read the detailed description

The aim of the study is to evaluate the safety and tolerability of NGM120 monotherapy in subjects with select advanced solid tumors (Part 1), NGM120 in combination with gemcitabine and Abraxane for the management of metastatic pancreatic cancer (Part 2), and NGM120 in metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed under 1 or more lines of ADT (Part 3), for up to 24 months of treatment.

Conditions: Pancreatic Cancer, Metastatic Castration-resistant Prostate Cancer, Bladder Cancer, Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer
Being tested: NGM120 30mg, NGM120 100mg, NGM120 30mg with Gemcitabine and Abraxane, NGM120 100mg with Gemcitabine and Abraxane, NGM120 100mg Q3W
Medical subject headings: Pancreatic Neoplasms, Urinary Bladder Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NGM120 30mgBiological
NGM120 30mg Subcutaneous Injection
NGM120 100mgBiological
NGM120 100mg Subcutaneous Injection
NGM120 30mg with Gemcitabine and AbraxaneBiological
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 100mg with Gemcitabine and AbraxaneBiological
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).
NGM120 100mg Q3WBiological
NGM120 100mg Subcutaneous Injection every 3 weeks
PlaceboOther
Placebo

Study groups in NCT04068896
Study group	Role	What they receive
Part 1 NGM120 30mg	Experimental	NGM120 30mg Subcutaneous Injection Receives: Biological: NGM120 30mg
Part 1 NGM120 100mg	Experimental	NGM120 100mg Subcutaneous Injection Receives: Biological: NGM120 100mg
Part 2 NGM120 30mg	Experimental	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). Receives: Biological: NGM120 30mg with Gemcitabine and Abraxane
Part 2 NGM120 100mg	Experimental	NGM120 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). Receives: Biological: NGM120 100mg with Gemcitabine and Abraxane
Part 3 NGM120 100mg Q3W	Experimental	NGM120 100mg Subcutaneous Injection NGM120 100mg Subcutaneous Injection every 3 weeks Receives: Biological: NGM120 100mg Q3W
Part 2 Placebo	Placebo comparator	Placebo 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). Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To Determine the Safety and Tolerability of NGM120 in Subjects
Number of Participants with NGM120/Placebo-Related Treatment Emergent Adverse Events
Measured: 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
Measured: 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
Measured: From enrollment to end of treatment up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 20198 Jan 2024

First posted28 Aug 2019
Study start16 Oct 2019
Primary completion21 Sep 2023
Study completion8 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pancreatic CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04068896
Sponsor's protocol ID: 18-0402
Status last verified: Mar 2025
First submitted: 22 Aug 2019
Last updated: 29 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04068896
Acronym / sponsor ID: 18-0402
Conditions: Pancreatic Cancer, Metastatic Castration-resistant Prostate Cancer, Bladder Cancer, Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: 16 Oct 2019 (actual)
Primary completion: 21 Sep 2023 (actual)
Study completion: 8 Jan 2024 (actual)
First posted: 28 Aug 2019 (actual)
Results: Posted 29 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Part 1 NGM120 30mg	Experimental	Biological: NGM120 30mgNGM120 30mg Subcutaneous Injection
Part 1 NGM120 100mg	Experimental	Biological: NGM120 100mgNGM120 100mg Subcutaneous Injection
Part 2 NGM120 30mg	Experimental	Biological: NGM120 30mg with Gemcitabine and AbraxaneNGM120 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	Experimental	Biological: NGM120 100mg with Gemcitabine and AbraxaneNGM120 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	Experimental	Biological: NGM120 100mg Q3WNGM120 100mg Subcutaneous Injection NGM120 100mg Subcutaneous Injection every 3 weeks
Part 2 Placebo	Placebo comparator	Other: PlaceboPlacebo 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NGM120 30mgNGM120 30mg Subcutaneous Injection	Biological	Part 1 NGM120 30mg
NGM120 100mgNGM120 100mg Subcutaneous Injection	Biological	Part 1 NGM120 100mg
NGM120 30mg with Gemcitabine and AbraxaneNGM120 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).	Biological	Part 2 NGM120 30mg
NGM120 100mg with Gemcitabine and AbraxaneNGM120 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).	Biological	Part 2 NGM120 100mg
NGM120 100mg Q3WNGM120 100mg Subcutaneous Injection every 3 weeks	Biological	Part 3 NGM120 100mg Q3W
PlaceboPlacebo	Other	Part 2 Placebo

Primary outcome

To Determine the Safety and Tolerability of NGM120 in Subjects
Time frame: From enrollment to end of treatment up to 24 months
Number of Participants with NGM120/Placebo-Related Treatment Emergent Adverse Events
To Determine the Safety and Tolerability of NGM120
Time frame: From enrollment to end of treatment up to 24 months
Discontinuation of investigational product due to toxicity
To Determine the Safety and Tolerability of NGM120
Time frame: From enrollment to end of treatment up to 24 months
Local injection-site symptom assessment as evidenced by incidence of injection-site reactions

Results and safety

Results posted to the registry on 29 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1 NGM120 30 mg	10	0
Part 1 NGM120 100 mg	10	1
Part 2 NGM120 30 mg	10	2
Part 2 NGM120 100 mg	31	4
Part 2 Placebo	20	0
Part 3 NGM120 100 mg	6	0

Primary outcome: To Determine the Safety and Tolerability of NGM120 in Subjects

Time frame: From enrollment to end of treatment up to 24 months. Count of participants. Unit: Participants

Measure	Part 1 NGM120 30mg n = 10	Part 1 NGM120 100mg n = 10	Part 2 NGM120 30mg n = 10	Part 2 NGM120 100mg n = 31	Part 2 Placebo n = 20	Part 3 NGM120 100mg n = 6
Value	1	6	6	17	12	2

Population analysed: Safety analysis set

Primary outcome: To Determine the Safety and Tolerability of NGM120

Time frame: From enrollment to end of treatment up to 24 months. Count of participants. Unit: Participants

Measure	Part 1 NGM120 30mg n = 10	Part 1 NGM120 100mg n = 10	Part 2 NGM120 30mg n = 10	Part 2 NGM120 100mg n = 31	Part 2 Placebo n = 20	Part 3 NGM120 100mg n = 6
Value	2	0	2	8	3	0

Population analysed: Safety analysis set

Primary outcome: To Determine the Safety and Tolerability of NGM120

Time frame: From enrollment to end of treatment up to 24 months. Count of participants. Unit: Participants

Measure	Part 1 NGM120 30mg n = 10	Part 1 NGM120 100mg n = 10	Part 2 NGM120 30mg n = 10	Part 2 NGM120 100mg n = 31	Part 2 Placebo n = 20	Part 3 NGM120 100mg n = 6
Value	0	1	0	4	0	0

Population analysed: Safety analysis set

Adverse events

Time frame: 3 years, 8 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 NGM120 30mg	5 of 10 (50%)	10 of 10 (100%)	3 of 10
Part 1 NGM120 100mg	3 of 10 (30%)	10 of 10 (100%)	1 of 10
Part 2 NGM120 30mg	5 of 10 (50%)	10 of 10 (100%)	3 of 10
Part 2 NGM120 100mg	26 of 31 (83.9%)	31 of 31 (100%)	19 of 31
Part 2 Placebo	10 of 20 (50%)	20 of 20 (100%)	17 of 20
Part 3 NGM120 100mg	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Pancreatic Cancer

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

NGM Study Director study director

NGM Biopharmaceuticals, Inc

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Determine the Safety and Tolerability of NGM120 in Subjects (time frame: From enrollment to end of treatment up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04068896.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.