Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy
NCT ID: NCT04068896
Last Updated: 2025-05-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
89 participants
INTERVENTIONAL
2019-10-16
2024-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Part 1 NGM120 30mg
NGM120 30mg Subcutaneous Injection
NGM120 30mg
NGM120 30mg Subcutaneous Injection
Part 1 NGM120 100mg
NGM120 100mg Subcutaneous Injection
NGM120 100mg
NGM120 100mg Subcutaneous Injection
Part 2 NGM120 30mg
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 30mg with Gemcitabine and Abraxane
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).
Part 2 NGM120 100mg
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).
NGM120 100mg with Gemcitabine and Abraxane
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).
Part 3 NGM120 100mg Q3W
NGM120 100mg Subcutaneous Injection NGM120 100mg Subcutaneous Injection every 3 weeks
NGM120 100mg Q3W
NGM120 100mg Subcutaneous Injection every 3 weeks
Part 2 Placebo
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).
Placebo
Placebo
Interventions
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NGM120 30mg
NGM120 30mg Subcutaneous Injection
NGM120 100mg
NGM120 100mg Subcutaneous Injection
NGM120 30mg with Gemcitabine and Abraxane
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 Abraxane
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 Q3W
NGM120 100mg Subcutaneous Injection every 3 weeks
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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.
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
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.
18 Years
ALL
No
Sponsors
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NGM Biopharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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NGM Study Director
Role: STUDY_DIRECTOR
NGM Biopharmaceuticals, Inc
Locations
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NGM Clinical Study Site
Tucson, Arizona, United States
NGM Clinical Study Site
Los Angeles, California, United States
NGM Clinical Study Site
Los Angeles, California, United States
NGM Clinical Study Site
Sacramento, California, United States
NGM Clinical Study Site
San Diego, California, United States
NGM Clinical Study Site
Santa Monica, California, United States
NGM Clinical Study Site
Aurora, Colorado, United States
NGM Clinical Study Site
Washington D.C., District of Columbia, United States
NGM Clinical Study Site
Miami, Florida, United States
NGM Clinical Study Site
Chicago, Illinois, United States
NGM Clinical Study Site
Baltimore, Maryland, United States
NGM Clinical Study Site
Cincinnati, Ohio, United States
NGM Clinical Study Site
Philadelphia, Pennsylvania, United States
NGM Clinical Study Site
Charleston, South Carolina, United States
NGM Clinical Study Site
Myrtle Beach, South Carolina, United States
NGM Clinical Study Site
Nashville, Tennessee, United States
NGM Clinical Study Site
Dallas, Texas, United States
NGM Clinical Study Site
Houston, Texas, United States
NGM Clinical Study Site
Seattle, Washington, United States
NGM Clinical Study Site
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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18-0402
Identifier Type: -
Identifier Source: org_study_id
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