Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

Overview

Información sobre este estudio

This is an open-label, two-part, multiple study to evaluate the safety and tolerability of DS-8201a in patients with advanced solid malignant tumors.

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:

  • Eastern Cooperative Oncology Group performance status( PS) of 0 or 1.
  • Left Ventricular Ejection Fraction (LVEF) ≥ 50%

Part 1:

  • Advanced/unresectable or metastatic breast cancer or gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.

Part 2a:

  • Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
  • Treated with ado-trastuzumab emtansine (T-DM1)

Part 2b:

  • Advanced gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
  • Treated with trastuzumab

Part 2c:

  • Advanced breast cancer with HER2 low expression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.

Part 2d:

  • Advanced solid malignant tumor with HER2 expression other than breast cancer and gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.

Exclusion Criteria:

  • Has a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.
  • Has a medical history of myocardial infarction or unstable angina.
  • Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
  • Has a medical history of clinically significant lung diseases

More information

Publicaciones

Publications are currently not available
.
CLS-20391630

Mayo Clinic Footer