Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate 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).
Checked against the public recordLast updated May 29, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- NGM Biopharmaceuticals, Inc
- Interventions being studied
- Biological: NGM120 30mg; Biological: NGM120 100mg; Biological: NGM120 30mg with Gemcitabine and Abraxane; Biological: NGM120 100mg with Gemcitabine and Abraxane; Biological: NGM120 100mg Q3W; Other: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria (Part 1 and 2): 1. Have histologically confirmed metastatic pancreatic adenocarcinoma. Recurrent unresectable pancreatic cancer is acceptable as long as the treatment is first-line. 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. Inclusion Criteria (Part 3 Prostate Cancer): 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 (All parts): 1. 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. 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- NGM Clinical Study SiteTucson, Arizona
- NGM Clinical Study SiteLos Angeles, California
- NGM Clinical Study SiteLos Angeles, California
- NGM Clinical Study SiteSacramento, California
- NGM Clinical Study SiteSan Diego, California
- NGM Clinical Study SiteSanta Monica, California
- NGM Clinical Study SiteAurora, Colorado
- NGM Clinical Study SiteWashington D.C., District of Columbia
- NGM Clinical Study SiteMiami, Florida
- NGM Clinical Study SiteChicago, Illinois
- NGM Clinical Study SiteBaltimore, Maryland
- NGM Clinical Study SiteCincinnati, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 29, 2025. Always confirm current availability with the study team.