IRB #

STUDY00020408

Title

A Phase 1a/b Dose-Escalation 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

Principal Investigator

Charles Lopez

Study Purpose

Part 1 (Phase 1a): The purpose of this study is to test the safety of a study drug , NGM120, in participants with advanced pancreatic, colorectal, esophageal, and gastric cancer.

Part 2 (Phase 1b): The purpose of this study is to test the safety of a study drug, NGM120, combined with standard therapy, gemcitabine and nab-paclitaxel in participants with advanced pancreatic cancer.

Medical Condition(s)

pancreatic
colorecta
esophageal
gastric cancer

Eligibility Criteria

Inclusion Criteria:
-Males and females 18 years or older
-Have a life expectancy of at least 12 weeks
-Part 1 only: Histologically confirmed advanced or metastatic colorectal, pancreatic, gastric, or esophageal cancer
-Part 2 only: Histologically confirmed advanced or metastatic pancreatic

Exclusion Criteria:
-Use of immunosuppressive medications within 14 days screening
-Active infections or other serious underlying significant medical illness
-

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Up to 23 months

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

NGM Biopharmaceuticals, Inc.

Recruitment End

09/01/2025

Compensation Provided

Yes

Compensation

Participants will be given a Fitbit device as part of the study. Participants will be given the option to keep the Fitbit if a before study procedures and at least 1 follow-up visit are completed.


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