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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

Description

Brief Summary
Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer.


Phase

N/A

Inclusion and Exclusion Criteria

  • Have histologically confirmed advanced or metastatic castration-resistant prostate cancer, bladder cancer, melanoma, non-small cell lung cancer, pancreatic cancer, colorectal cancer, gastric cancer, esophageal cancer, ovarian cancer, and head neck squamous cell carcinoma. Or, 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.

  • 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 infection. -

Sites

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Presentado por SC CTSI