A Phase I Study of BTRC4017A in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Official Title

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of BTRC4017A Administered Intravenously in Patients With Locally Advanced or Metastatic HER2-Expressing Cancers

Summary:

This study will evaluate the safety, tolerability, and pharmacokinetics of BTRC4017A in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.

Trial Description

Primary Outcome:

• Percentage of Participants with Adverse Events

• Serum Concentration of BTRC4017A
• Area Under the Serum Concentration vs. Time Curve (AUC) of BTRC4017A
• Maximum Observed Serum Concentration (Cmax) of BTRC4017A
• Minimum Observed Serum Concentration (Cmin) of BTRC4017A
• Clearance (CL) of BTRC4017A
• Volume of Distribution at Steady State (Vss) of BTRC4017A
• 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 BTRC4017A

View this trial on ClinicalTrials.gov