A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumours

Official Title

A Phase 1, First In Human Study of DS-1055a in Subjects With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumours

Summary:

The purpose of this study is to assess the safety and tolerability of DS-1055a in participants with relapsed or refractory locally advanced or metastatic solid tumours for which no standard treatment is available.

Trial Description

Primary Outcome:

• Number of participants with dose-limiting toxicities
• Number of participants with adverse events

Secondary Outcome:

• Maximum Serum Concentration (Cmax)
• Time to Reach Maximum Serum Concentration (Tmax)
• Area Under the Serum Concentration-Time Curve Up to Last Quantifiable Time (AUClast) and During Dosing Interval (AUCtau)
• Minimum Observed Concentration (Ctrough)
• The Incidence of Anti-Drug Antibodies (ADA) and Other Antibodies

This Phase 1, open-label, non-randomized, dose escalation, first-in-human study will assess the safety and tolerability of DS-1055a, determine the maximum tolerated dose of DS-1055a, pharmacokinetic (PK) properties of DS-1055a, and the incidence of anti-drug antibodies (ADAs) against DS-1055a and other antibodies.

View this trial on ClinicalTrials.gov