Safety and Bioimaging Trial of DS-8895a in Patients With Advanced EphA2 Positive Cancers

PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

December 9, 2014

Primary Completion Date

September 8, 2016

Study Completion Date

September 8, 2016

Conditions
Malignant Solid TumorMetastatic EphA2 Positive Cancer
Interventions
DRUG

DS-8895a 1 mg/kg

Patients received infusions with \^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 1 mg/kg on Days 8 and 22, and \^89Zr-Df-DS-8895a at a dose of 1 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.

DRUG

DS-8895a 3 mg/kg

Patients received infusions with \^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 3 mg/kg on Days 8 and 22, and \^89Zr-Df-DS-8895a at a dose of 3 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.

DRUG

DS-8895a 10 mg/kg

Patients were to receive infusions with \^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 10 mg/kg on Days 8 and 22, and \^89Zr-Df-DS-8895a at a dose of 10 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.

Trial Locations (1)

3084

Austin Health, Heidelberg

All Listed Sponsors
collaborator

Daiichi Sankyo Co., Ltd.

INDUSTRY

collaborator

Austin Health

OTHER_GOV

lead

Ludwig Institute for Cancer Research

OTHER