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; Other: Placebo

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

Brief Summary

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

Detailed Description

Not available

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: 2024-07
• Last Update Submitted: 2024-07-06
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
NGM120 Dose 6	NGM120	NGM120 Subcutaneous Injection
NGM120 Dose 3	NGM120	NGM120 Subcutaneous Injection
NGM120 Dose 1	NGM120	NGM120 Subcutaneous Injection
NGM120 Dose 4	NGM120	NGM120 Subcutaneous Injection
NGM120 Dose 2	NGM120	NGM120 Subcutaneous Injection
Placebo	Placebo	Placebo
NGM120 Dose 5	NGM120	NGM120 Subcutaneous Injection

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	12 weeks	Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug
Number of Patients with Clinically Significant Laboratory Abnormalities:	12 weeks	Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing.
Number of patients with Dose-Limiting Toxicities:	12 weeks	A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0 and is considered by the investigator to be clinically relevant and attributed to the study treatment during the first 28 days after the first dose of study treatment.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of NGM120	19 weeks	Pharmacokinetics (PK) of NGM120 by measuring serum concentration of NGM120 at specified timepoints
Immunogenicity against NGM120	19 weeks	Immunogenicity against NGM120 by measuring percentage of subjects to develop antidrug antibodies and neutralizing antibodies
Assessment of Antitumor and Anticachexia Activity Assessed using the RECIST Version 1.1 criteria	19 weeks	Assessment of Antitumor and Anticachexia Activity Assessed using the RECIST Version 1.1 criteria
Body weight during therapy with NGM120	19 weeks	Body weight during therapy with NGM120 by measuring change in body weight (in lb).
Skeletal muscle index during therapy with NGM120	19 weeks	Skeletal muscle index during therapy with NGM120 by measuring skeletal muscle mass and adiposity at level of L3 on serial CT scan.

Trial Locations

Locations (1)

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