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NCT04068896 · OUTCOME

To Determine the Safety and Tolerability of NGM120

Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy · Source last updated 2025-05-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From enrollment to end of treatment up to 24 months

What was measured

Local injection-site symptom assessment as evidenced by incidence of injection-site reactions

Analysis population: Safety analysis set

Groups in this outcome

Part 1 NGM120 30mg

NGM120 30mg Subcutaneous Injection

Part 1 NGM120 100mg

NGM120 100mg Subcutaneous Injection

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).

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).

Part 2 Placebo

Placebo 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).

Part 3 NGM120 100mg

NGM120 100mg Subcutaneous Injection

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1 NGM120 30mg10
Part 1 NGM120 100mg10
Part 2 NGM120 30mg10
Part 2 NGM120 100mg31
Part 2 Placebo20
Part 3 NGM120 100mg6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 NGM120 30mg0Not reportedNot reportedNot reportedNot reported
Part 1 NGM120 100mg1Not reportedNot reportedNot reportedNot reported
Part 2 NGM120 30mg0Not reportedNot reportedNot reportedNot reported
Part 2 NGM120 100mg4Not reportedNot reportedNot reportedNot reported
Part 2 Placebo0Not reportedNot reportedNot reportedNot reported
Part 3 NGM120 100mg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      31
    5. group Id
      OG004
      value
      20
    6. group Id
      OG005
      value
      6
    units
    Participants
description
Local injection-site symptom assessment as evidenced by incidence of injection-site reactions
groups
  1. description
    NGM120 30mg Subcutaneous Injection
    id
    OG000
    title
    Part 1 NGM120 30mg
  2. description
    NGM120 100mg Subcutaneous Injection
    id
    OG001
    title
    Part 1 NGM120 100mg
  3. description
    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).
    id
    OG002
    title
    Part 2 NGM120 30mg
  4. description
    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).
    id
    OG003
    title
    Part 2 NGM120 100mg
  5. description
    Placebo 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).
    id
    OG004
    title
    Part 2 Placebo
  6. description
    NGM120 100mg Subcutaneous Injection
    id
    OG005
    title
    Part 3 NGM120 100mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set
reporting Status
POSTED
time Frame
From enrollment to end of treatment up to 24 months
title
To Determine the Safety and Tolerability of NGM120
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice