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

Conditions

• Bladder Cancer
• Colorectal Cancer
• Esophageal Cancer
• Gastric Cancer
• Head Neck Squamous Cell Carcinoma
• Melanoma
• Metastatic Castration-resistant Prostate Cancer
• Non-small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer

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)

Find similar trials in Tucson, AZ

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