Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma

Official Title

An Open-Label Multicentre Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma

Summary:

The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.

Trial Description

Primary Outcome:

• Number of Participants with Dose-limiting Toxicities (DLTs)
• Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

• Area under the Plasma Concentration-time Curve from Time 0 Through the Last Measurable Point (AUC0-t) of H3B-6527
• Maximum Observed Plasma Concentration (Cmax) of H3B-6527
• Time of Maximum Observed Plasma Concentration (tmax) of H3B-6527
• Objective Response Rate (ORR)
• Duration of Response (DOR)
• Progression-free Survival (PFS)
• Overall Survival (OS)
• Time to Response

View this trial on ClinicalTrials.gov