NCT04068896

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: NGM Biopharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The aim of the study is to evaluate the safety and tolerability of NGM120 monotherapy in subjects with select advanced solid tumors (Part 1), NGM120 in combination with gemcitabine and Abraxane for the management of metastatic pancreatic cancer (Part 2), and NGM120 in metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed under 1 or more lines of ADT (Part 3), for up to 24 months of treatment.

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
• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	NGM120 30mg	NGM120 30mg Subcutaneous Injection
BIOLOGICAL	NGM120 100mg	NGM120 100mg Subcutaneous Injection
BIOLOGICAL	NGM120 30mg with Gemcitabine and Abraxane	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).
BIOLOGICAL	NGM120 100mg with Gemcitabine and Abraxane	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).
BIOLOGICAL	NGM120 100mg Q3W	NGM120 100mg Subcutaneous Injection every 3 weeks
OTHER	Placebo	Placebo

Timeline

• Start date: 2019-10-16
• Primary completion: 2023-09-21
• Completion: 2024-01-08
• First posted: 2019-08-28
• Last updated: 2025-05-29
• Results posted: 2025-05-29

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study