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

Phase 1

Completed

• Conditions: Metastatic Castration-resistant Prostate Cancer; Colorectal Cancer; Esophageal Cancer; Pancreatic Cancer; Prostate Cancer; Bladder Cancer; Melanoma; Gastric Cancer; Ovarian Cancer; Head Neck Squamous Cell Carcinoma
• Interventions: Biological: NGM120 30mg; Biological: NGM120 100mg; Biological: NGM120 30mg with Gemcitabine and Abraxane; Biological: NGM120 100mg with Gemcitabine and Abraxane; Biological: NGM120 100mg Q3W; Other: Placebo

• Registration Number: NCT04068896
• Lead Sponsor: NGM Biopharmaceuticals, Inc

Brief 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.

Study Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Study Start: 2019-10-16
• Primary Completion: 2023-09-21
• Study Completion: 2024-01-08
• Status Verified: 2025-03
• Results First Submitted: 2025-03-04
• Results First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Results First Posted: 2025-05-29
• Last Update Posted: 2025-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1 NGM120 30mg	NGM120 30mg	NGM120 30mg Subcutaneous Injection
Part 1 NGM120 100mg	NGM120 100mg	NGM120 100mg Subcutaneous Injection
Part 2 NGM120 30mg	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).
Part 2 NGM120 100mg	NGM120 100mg with Gemcitabine and Abraxane	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 3 NGM120 100mg Q3W	NGM120 100mg Q3W	NGM120 100mg Subcutaneous Injection NGM120 100mg Subcutaneous Injection every 3 weeks
Part 2 Placebo	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 Measures

Name	Time	Method
To Determine the Safety and Tolerability of NGM120 in Subjects	From enrollment to end of treatment up to 24 months	Number of Participants with NGM120/Placebo-Related Treatment Emergent Adverse Events
To Determine the Safety and Tolerability of NGM120	From enrollment to end of treatment up to 24 months	Local injection-site symptom assessment as evidenced by incidence of injection-site reactions

Trial Locations

Locations (1)

NGM Clinical Study Site; 🇺🇸 Milwaukee, Wisconsin, United States