Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
89
NGM120 30mg Subcutaneous Injection
NGM120 100mg Subcutaneous Injection
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 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 Subcutaneous Injection every 3 weeks
Placebo
NGM Clinical Study Site
Tucson, Arizona, United States
NGM Clinical Study Site
Los Angeles, California, United States
NGM Clinical Study Site
Los Angeles, California, United States
NGM Clinical Study Site
Sacramento, California, United States
NGM Clinical Study Site
San Diego, California, United States
NGM Clinical Study Site
Santa Monica, California, United States
NGM Clinical Study Site
Aurora, Colorado, United States
NGM Clinical Study Site
Washington D.C., District of Columbia, United States
NGM Clinical Study Site
Miami, Florida, United States
NGM Clinical Study Site
Chicago, Illinois, United States
...and 10 more locations
To Determine the Safety and Tolerability of NGM120 in Subjects
Number of Participants with NGM120/Placebo-Related Treatment Emergent Adverse Events
Time frame: From enrollment to end of treatment up to 24 months
To Determine the Safety and Tolerability of NGM120
Discontinuation of investigational product due to toxicity
Time frame: From enrollment to end of treatment up to 24 months
To Determine the Safety and Tolerability of NGM120
Local injection-site symptom assessment as evidenced by incidence of injection-site reactions
Time frame: From enrollment to end of treatment up to 24 months
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