Ovarian Cancer Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria (Part 1 and 2):

Have histologically confirmed metastatic pancreatic adenocarcinoma. Recurrent unresectable pancreatic cancer is acceptable as long as the treatment is first-line.
Have not received any approved chemotherapy, except in the adjuvant setting.
Life expectancy of at least 12 weeks
Male subjects must agree to use contraception as per protocol during the treatment period and for at least 90 days after the last study treatment administration and refrain from donating sperm during this period.
Provision of an archival tumor sample (within 5 years). If an archival sample is unavailable, a fresh biopsy can be obtained during Screening. If archival tissue or biopsy sample is unavailable, the subject is ineligible.

Inclusion Criteria (Part 3 Prostate Cancer):

Metastatic, castrate resistance, histologically confirmed prostate cancer; continuous medical castration for ≥8 weeks prior to screening.
Effective castration with serum testosterone levels <0.5 ng/mL (50 ng/dL; 1.7 nmol/L).
Have serum GDF15 levels ≥1300 pg/mL.
Have experienced PSA progression under 1 or more lines of ADT in the absence or presence of radiographic and/or clinical progression, who decline or are not eligible to receive chemotherapy.
Have had PSA doubling time of >3 months.

Exclusion Criteria (All parts):

Subject was using immunosuppressive medications within 14 days before Screening with the exception of topical (intranasal, inhaled, and local injection), systemic (prednisone equivalent 10 mg/day or less), or as needed for hypersensitivity reactions such as computed tomography (CT) scan premedication.
Subject has active infections or other serious underlying significant medical illness, abnormal and clinically significant laboratory findings or psychiatric illness/social situation.
Subject is using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants, cochlear implants, or other electronic medical equipment.
Subject has documented immunodeficiency or organ transplant.
Subject has an untreated central nervous system disease, leptomeningeal disease or cord compression.
Subject has a history, or presence, of significant cardiovascular diseases; including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months before randomization, congestive heart failure > New York Heart Association Class II, severe peripheral vascular disease, corrected QT (QTc) prolongation >470 msec, clinically significant pericardial effusion.
Subject has a history or presence of documented inflammatory bowel disease.
Subject is known to be positive for human immunodeficiency virus (HIV) infection.

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

75

Study ID:

NCT04068896

Recruitment Status:

Active, not recruiting

Sponsor:

NGM Biopharmaceuticals, Inc

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There are 22 Locations for this study

See Locations Near You

NGM Clinical Study Site
Tucson Arizona, 85719, United States
NGM Clinical Study Site
Los Angeles California, 90048, United States
NGM Clinical Study Site
Los Angeles California, 90084, United States
NGM Clinical Study Site
Sacramento California, 98517, United States
NGM Clinical Study Site
San Diego California, 92123, United States
NGM Clinical Study Site
Santa Monica California, 90404, United States
NGM Clinical Study Site
Aurora Colorado, 80045, United States
NGM Clinical Study Site
Washington District of Columbia, 20007, United States
NGM Clinical Study Site
Miami Florida, 33136, United States
NGM Clinical Study Site
Chicago Illinois, 60611, United States
NGM Clinical Study Site
Baltimore Maryland, 21201, United States
NGM Clinical Study Site
Omaha Nebraska, 68130, United States
NGM Clinical Study Site
Charlotte North Carolina, 28204, United States
NGM Clinical Study Site
Cincinnati Ohio, 45219, United States
NGM Clinical Study Site
Philadelphia Pennsylvania, 19111, United States
NGM Clinical Study Site
Charleston South Carolina, 29425, United States
NGM Clinical Study Site
Myrtle Beach South Carolina, 29572, United States
NGM Clinical Study Site
Nashville Tennessee, 37203, United States
NGM Clinical Study Site
Dallas Texas, 75390, United States
NGM Clinical Study Site
Houston Texas, 77030, United States
NGM Clinical Study Site
Seattle Washington, 98101, United States
NGM Clinical Study Site
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

75

Study ID:

NCT04068896

Recruitment Status:

Active, not recruiting

Sponsor:


NGM Biopharmaceuticals, Inc

How clear is this clinincal trial information?

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