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Protocol # 17-609

Status

Recruiting

Description

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.

Condition

  • Advanced Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • Liver Cancer
  • Liver Neoplasms
  • Hepatic Cancer
  • Hepatic Carcinoma

Interventions

  • H3B-6527

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

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

Secondary Outcome:

  • 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

Enrollment

128

Study Start Date

July 2016

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

H3 Biomedicine Inc.

Source

Eisai Inc.

Official title

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

Clinicaltrials.gov Identifier

NCT02834780

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.