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Bobbi Drais

US Regulatory

September 6, 2024/by Ilona Margolis
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https://etira.life/wp-content/uploads/2024/09/Bobbi-1.png 434 349 Ilona Margolis https://etira.life/wp-content/uploads/2023/11/etira-life-logo-home.png Ilona Margolis2024-09-06 12:28:032024-12-03 11:08:23Bobbi Drais

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Inclusion criteria:
  • Patients must be at least 18 years of age at the time of signing the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Patients must have histologically or cytologically confirmed solid tumor, primarily including but not limited to breast, ovarian, pancreatic, endometrial, and hepatocellular carcinoma, that is advanced unresectable and/or metastatic disease for whom standard therapies do not exist or are no longer effective
  • Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Adequate baseline organ function and hematologic function
  • Life expectancy >3 months
Exclusion criteria
  • Systemic anti-cancer therapy within 4 weeks of first dose of study drug
  • Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
  • Uncontrolled intercurrent illnesses
  • Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease.