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

NCT02252211 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-10-12

Study results available
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Summary

This was a Phase 1, dose-escalation, non-randomized, open-label, single-center study of DS-8895a in patients with advanced or metastatic Ephrin type-A receptor 2 (EphA2)-positive cancers. The primary study objective was to determine the safety of DS-8895a, with secondary objectives of determining the biodistribution, tumor uptake (bioimaging), pharmacokinetics (PK), antitumor and pharmacodynamic response, and correlations between pharmacodynamics and clinical outcomes, as appropriate.

Conditions

  • Malignant Solid Tumor
  • Metastatic 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.

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    collaborator INDUSTRY

  • Austin Health

    collaborator OTHER_GOV

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • Andrew Scott, MD · Austin Health, Melbourne, Australia

  • Hui Gan, MD, PhD · Austin Health, Melbourne, Australia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-09
Primary Completion
2016-09-08
Completion
2016-09-08

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02252211 on ClinicalTrials.gov