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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
NGM Biopharmaceuticals, Inc
Study ID
NCT04068896
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NGM120 30mg — BIOLOGICAL
    NGM120 30mg Subcutaneous Injection
  • NGM120 100mg — BIOLOGICAL
    NGM120 100mg Subcutaneous Injection
  • NGM120 30mg with Gemcitabine and Abraxane — BIOLOGICAL
    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 — BIOLOGICAL
    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 — BIOLOGICAL
    NGM120 100mg Subcutaneous Injection every 3 weeks
  • Placebo — OTHER
    Placebo

Study Details

Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3).

Key Dates

First listed
Aug 28, 2019
Start date
Oct 16, 2019
Status verified
Mar 2025
Primary completion
Sep 21, 2023
Completion
Jan 8, 2024

Study Design

Enrollment
89 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 NGM120 30mg
    NGM120 30mg Subcutaneous Injection
  • Experimental: Part 1 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).
  • 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).
  • Experimental: Part 3 NGM120 100mg Q3W
    NGM120 100mg Subcutaneous Injection 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).

Primary Outcome Measure

To Determine the Safety and Tolerability of NGM120 in Subjects [ Time Frame: From enrollment to end of treatment up to 24 months ]

Locations (20)

FacilityCityStateZIPSite coordinators
NGM Clinical Study SiteTucsonArizona85719-
NGM Clinical Study SiteLos AngelesCalifornia90048-
NGM Clinical Study SiteLos AngelesCalifornia90084-
NGM Clinical Study SiteSacramentoCalifornia98517-
NGM Clinical Study SiteSan DiegoCalifornia92123-
NGM Clinical Study SiteSanta MonicaCalifornia90404-
NGM Clinical Study SiteAuroraColorado80045-
NGM Clinical Study SiteWashington D.C.District of Columbia20007-
NGM Clinical Study SiteMiamiFlorida33136-
NGM Clinical Study SiteChicagoIllinois60611-
NGM Clinical Study SiteBaltimoreMaryland21201-
NGM Clinical Study SiteCincinnatiOhio45219-
NGM Clinical Study SitePhiladelphiaPennsylvania19111-
NGM Clinical Study SiteCharlestonSouth Carolina29425-
NGM Clinical Study SiteMyrtle BeachSouth Carolina29572-
NGM Clinical Study SiteNashvilleTennessee37203-
NGM Clinical Study SiteDallasTexas75390-
NGM Clinical Study SiteHoustonTexas77030-
NGM Clinical Study SiteSeattleWashington98101-
NGM Clinical Study SiteMilwaukeeWisconsin53226-

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