A Study to Assess the Safety, Tolerability, and Effectiveness of KPT-9274 to Treat Patients who have Advanced Solid Malignancies or Non-Hodgkin's Lymphoma

Overview

Información sobre este estudio

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of oral KPT-9274 for the treatment of patients who have advanced solid malignancies or non-Hodgkin's lymphoma.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  • Advanced solid malignancies or Non-Hodgkins lymphoma for which all standard therapeutic options considered useful have been exhausted
  • Must have objective evidence of progressive disease on study entry
  • Measureable Advanced solid malignancy disease as defined by RECIST 1.1
  • Measureable non-Hodgkins lymphoma disease including target lesion(s) as defined by the Lugano Classification for initial evaluation and staging
  • Must have a site of disease amenable to biopsy and be a candidate for biopsy
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  • For dose expansion phase of KPT-9274 + niacin ER cohort only, NAPRT1 and IDH1 tumor status must be determined at the central laboratory prior to enrollment
  • Life expectancy of ≥3 months

Exclusion Criteria

  • Known central nervous system (CNS) disease or leptomeningeal involvement, regardless of response to prior therapy
  • Major surgery within 4 weeks before C1D1
  • Active infection with completion of therapeutic antibiotics, antivirals, or antifungals within one week prior to C1D1
    • Prophylactic antibiotics, antivirals or antifungals are permitted
  • Known history of Human Immunodeficiency Virus (HIV)
    • HIV testing is not required as part of this study
  • Known, active hepatitis A, B, or C infection or known to be positive for HCV RNA or HBsAg (HBV surface antigen)
  • Significant diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea that could interfere with the absorption of KPT-9274
  • Active peptic ulcer disease or other active gastrointestinal bleeds

More information

Publicaciones

Publications are currently not available
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CLS-20260196

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