A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Titre officiel

A Phase Ia/Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Runimotamab Administered Intravenously as a Single Agent and in Combination With Trastuzumab in Patients With Locally Advanced or Metastatic HER2-Expressing Cancers

Sommaire:

This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.

Description de l'essai

Primary Outcome:

• Percentage of Participants with Adverse Events

• Serum Concentration of Runimotamab
• Area Under the Serum Concentration vs. Time Curve (AUC) of Runimotamab
• Maximum Observed Serum Concentration (Cmax) of Runimotamab
• Minimum Observed Serum Concentration (Cmin) of Runimotamab
• Clearance (CL) of Runimotamab
• Volume of Distribution at Steady State (Vss) of Runimotamab
• Objective Response (OR) as Determined by the Investigator According to Response Evaluation Criteria In Solid Tumours v1.1 (RECIST v1.1)
• Duration of Response (DOR)
• Anti-Drug Antibody (ADA) Levels of Runimotamab

Voir cet essai sur ClinicalTrials.gov