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

Titre officiel

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

Sommaire:

Le but de cette étude est d’évaluer l’innocuité et la tolérabilité du DS-1055a chez des participants présentant une tumeur solide localement avancée ou métastatique, récidivante ou réfractaire, pour laquelle aucun traitement de référence n’est disponible.

Description de l'essai

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.

Voir cet essai sur ClinicalTrials.gov