Clinical Trials /

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

NCT04068896

Description:

Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer.

Related Conditions:
  • Bladder Carcinoma
  • Colorectal Carcinoma
  • Esophageal Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Pancreatic Adenocarcinoma
  • Pancreatic Carcinoma
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy
  • Official Title: A Phase 1a/b Dose-Escalation 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

Clinical Trial IDs

  • ORG STUDY ID: 18-0402
  • NCT ID: NCT04068896

Conditions

  • 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

Interventions

DrugSynonymsArms
NGM120NGM120 Dose 1
NGM120NGM120 Dose 2
NGM120NGM120 Dose 3
NGM120NGM120 Dose 4
NGM120NGM120 Dose 5
NGM120NGM120 Dose 6

Purpose

Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer.

Trial Arms

NameTypeDescriptionInterventions
NGM120 Dose 1ExperimentalNGM120 Subcutaneous Injection
  • NGM120
NGM120 Dose 2ExperimentalNGM120 Subcutaneous Injection
  • NGM120
NGM120 Dose 3ExperimentalNGM120 Subcutaneous Injection
  • NGM120
NGM120 Dose 4ExperimentalNGM120 Subcutaneous Injection
  • NGM120
NGM120 Dose 5ExperimentalNGM120 Subcutaneous Injection
  • NGM120
NGM120 Dose 6ExperimentalNGM120 Subcutaneous Injection
  • NGM120
PlaceboPlacebo ComparatorPlacebo

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Have histologically confirmed advanced or metastatic castration-resistant prostate
                 cancer, bladder cancer, melanoma, non-small cell lung cancer, pancreatic cancer,
                 colorectal cancer, gastric cancer, esophageal cancer, ovarian cancer, and head neck
                 squamous cell carcinoma.
    
                 Or,
    
                 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.
    
            Exclusion Criteria:
    
              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 infection.
    
                 -
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
    Time Frame:19 weeks
    Safety Issue:
    Description:The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.

    Secondary Outcome Measures

    Measure:Serum Concentration of NGM120
    Time Frame:19 weeks
    Safety Issue:
    Description:NGM120 concentration data by cohort.
    Measure:Assessment of Anticancer Activity
    Time Frame:19 weeks
    Safety Issue:
    Description:Assessed using the RECIST Version 1.1 criteria

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:NGM Biopharmaceuticals, Inc

    Last Updated

    November 18, 2019