Phase 1/2 Open-Label Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX295 in Subjects with Wild-Type TP53 Advanced Solid Tumors


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Study Status:






The purpose of the study is to test the following: 1) The safety and tolerability (how you feel when you take the drug) of the study drug, 2) The pharmacokinetics (PK) (how the study drug is absorbed within your body, spread throughout your body, and eliminated from your body) of the study drug, 3) The pharmacodynamics (PD) (how the study drug affects certain proteins related to your cancer) of the study drug, 4) The initial clinical effect (how the study drug affects your cancer) of the study drug, and 5) To determine the most appropriate dose (strength) and how often the drug should be taken. The drug being tested in this study, ASTX295, is investigational. This means it has not been approved for the treatment of cancer in any country. This is the first clinical study of ASTX295 in humans. In this study, all subjects will receive study drug; there is no placebo treatment. There are 2 Phases in this study, Phase 1 (early stage) and Phase 2 (late stage).

Are you Eligible? (Inclusion Criteria)

  • • Do you have a solid tumor that continues to grow or cannot be removed via
  • surgery, or for which standard therapy does not exist?
  • • Do you have documented wild-type TP53 gene status?
  • • Are you a male or female 18 years of age or older?

Specialty Area(s)

Bladder Cancer , Breast Cancer, Colon and Rectal Cancer, Ovarian Cancer, Head and Neck/Oral Cancers, Kidney Cancer/Adrenal Cancer, Lung cancer, Melanoma, Pancreatic Cancer, Prostate Cancer, Soft Tissue Sarcoma, Stomach Cancer, Precision Oncology, Immunotherapy

Principal Investigator

Profile Headshot
  • Deputy Director, Division of Neuro-Oncology

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032