Safety and Bioimaging Trial of DS-8895a in Patients With Advanced EphA2 Positive Cancers — LUD2014-002  

Malignant Solid Tumor Clinical Trial

Official title: A Phase I Safety and Bioimaging Trial of DS-8895a in Patients With Advanced or Metastatic EphA2 Positive Cancers

Status Completed

Clinical Trial 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.

Clinical Trial Description

Patients received an initial ^89Zr trace-labelled infusion of DS-8895a on Day 1, followed by safety assessments, positron emission tomography (PET) imaging, and PK sampling over a 1-week period. DS-8895a was infused again on Days 8, 22, and 36. The Day 36 infusion of DS-8895a was also trace labelled with ^89Zr, with subsequent PET imaging and PK sampling. Four dose levels (1, 3, 10 and 20 mg/kg) were to be evaluated, with 3 to 6 patients entered at each dose level. Patients who responded or had stable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression, with restaging performed by computed tomography (CT) scans every 6 weeks. ;

Related Conditions & MeSH terms

• Malignant Solid Tumor
• Metastatic EphA2 Positive Cancer

• NCT number: NCT02252211
• Study type: Interventional
• Source: Ludwig Institute for Cancer Research
• Status: Completed
• Phase: Phase 1
• Start date: December 9, 2014
• Completion date: September 8, 2016