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Clinical Trial Record

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

2019-10-16

2023-09-21

2024-01-08

89

Study Overview

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).

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.

  • 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
  • Prostate Cancer
  • 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
  • 18-0402

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-08-22  

2025-03-04  

2025-05-23  

2019-08-23  

2025-05-23  

2025-05-29  

2019-08-28  

2025-05-29  

2025-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Sequential

Masking:
Quadruple

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Part 1 NGM120 30mg

NGM120 30mg Subcutaneous Injection

BIOLOGICAL: NGM120 30mg

  • NGM120 30mg Subcutaneous Injection
EXPERIMENTAL: Part 1 NGM120 100mg

NGM120 100mg Subcutaneous Injection

BIOLOGICAL: NGM120 100mg

  • NGM120 100mg Subcutaneous Injection
EXPERIMENTAL: 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).

BIOLOGICAL: 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).
EXPERIMENTAL: 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).

BIOLOGICAL: 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).
EXPERIMENTAL: Part 3 NGM120 100mg Q3W

NGM120 100mg Subcutaneous Injection NGM120 100mg Subcutaneous Injection every 3 weeks

BIOLOGICAL: NGM120 100mg Q3W

  • NGM120 100mg Subcutaneous Injection every 3 weeks
PLACEBO_COMPARATOR: 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).

OTHER: Placebo

  • Placebo
Primary Outcome MeasuresMeasure DescriptionTime Frame
To Determine the Safety and Tolerability of NGM120 in SubjectsNumber of Participants with NGM120/Placebo-Related Treatment Emergent Adverse EventsFrom enrollment to end of treatment up to 24 months
To Determine the Safety and Tolerability of NGM120Discontinuation of investigational product due to toxicityFrom enrollment to end of treatment up to 24 months
To Determine the Safety and Tolerability of NGM120Local injection-site symptom assessment as evidenced by incidence of injection-site reactionsFrom enrollment to end of treatment up to 24 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • STUDY_DIRECTOR: NGM Study Director, NGM Biopharmaceuticals, Inc

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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