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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068896
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 30, 2022
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE August 22, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date August 30, 2022
Actual Study Start Date  ICMJE October 16, 2019
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2022)
  • Number of patients with Dose-Limiting Toxicities: [ Time Frame: 12 weeks ]
    A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0 and is considered by the investigator to be clinically relevant and attributed to the study treatment during the first 28 days after the first dose of study treatment.
  • Incidence of Adverse Events [ Time Frame: 12 weeks ]
    Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug
  • Number of Patients with Clinically Significant Laboratory Abnormalities: [ Time Frame: 12 weeks ]
    Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing.
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 19 weeks ]
The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2022)
  • Pharmacokinetics (PK) of NGM120 [ Time Frame: 19 weeks ]
    Pharmacokinetics (PK) of NGM120 by measuring serum concentration of NGM120 at specified timepoints
  • Immunogenicity against NGM120 [ Time Frame: 19 weeks ]
    Immunogenicity against NGM120 by measuring percentage of subjects to develop antidrug antibodies and neutralizing antibodies
  • Assessment of Antitumor and Anticachexia Activity Assessed using the RECIST Version 1.1 criteria [ Time Frame: 19 weeks ]
    Assessment of Antitumor and Anticachexia Activity Assessed using the RECIST Version 1.1 criteria
  • Body weight during therapy with NGM120 [ Time Frame: 19 weeks ]
    Body weight during therapy with NGM120 by measuring change in body weight (in lb).
  • Skeletal muscle index during therapy with NGM120 [ Time Frame: 19 weeks ]
    Skeletal muscle index during therapy with NGM120 by measuring skeletal muscle mass and adiposity at level of L3 on serial CT scan.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
  • Serum Concentration of NGM120 [ Time Frame: 19 weeks ]
    NGM120 concentration data by cohort.
  • Assessment of Anticancer Activity [ Time Frame: 19 weeks ]
    Assessed using the RECIST Version 1.1 criteria
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy
Official Title  ICMJE 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
Brief Summary Study of NGM120 in subjects with advanced solid tumors and and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Biological: NGM120
    NGM120 Dose 1
  • Biological: NGM120
    NGM120 Dose 2
  • Biological: NGM120
    NGM120 Dose 3
  • Biological: NGM120
    NGM120 Dose 4
  • Biological: NGM120
    NGM120 Dose 5
  • Biological: NGM120
    NGM120 Dose 6
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: NGM120 Dose 1
    NGM120 Subcutaneous Injection
    Intervention: Biological: NGM120
  • Experimental: NGM120 Dose 2
    NGM120 Subcutaneous Injection
    Intervention: Biological: NGM120
  • Experimental: NGM120 Dose 3
    NGM120 Subcutaneous Injection
    Intervention: Biological: NGM120
  • Experimental: NGM120 Dose 4
    NGM120 Subcutaneous Injection
    Intervention: Biological: NGM120
  • Experimental: NGM120 Dose 5
    NGM120 Subcutaneous Injection
    Intervention: Biological: NGM120
  • Experimental: NGM120 Dose 6
    NGM120 Subcutaneous Injection
    Intervention: Biological: NGM120
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2022)
75
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2019)
90
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: NGM Study Director 650-243-5555 ngm120@ngmbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04068896
Other Study ID Numbers  ICMJE 18-0402
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party NGM Biopharmaceuticals, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE NGM Biopharmaceuticals, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: NGM Study Director NGM Biopharmaceuticals, Inc
PRS Account NGM Biopharmaceuticals, Inc
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP