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

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ClinicalTrials.gov Identifier: NCT02834780
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc. ( H3 Biomedicine Inc. )

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Hepatocellular Carcinoma Liver Cancer Liver Neoplasms Hepatic Cancer Hepatic Carcinoma Cholangiocarcinoma Bile Duct Cancer Drug: H3B-6527 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 or Intrahepatic Cholangiocarcinoma
Actual Study Start Date : July 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: H3B-6527 (escalation and expansion)
Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
Drug: H3B-6527
H3B-6527 by mouth once or twice daily at specified doses.




Primary Outcome Measures :
  1. Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: Escalation Cycle 1 (21 days) ]
  2. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Escalation and Expansion continuously throughout the study until 30 days after treatment discontinuation (up to 36 months) ]

Secondary Outcome Measures :
  1. Area under the Plasma Concentration-time Curve from Time 0 Through the Last Measurable Point (AUC0-t) of H3B-6527 [ Time Frame: Escalation, Cycle 1 (21-day cycles): Days 1 and 8 pre-dose and at multiple time points (up to 24 hours) post-dose; Expansion, Cycle 1 (21-day cycles): Days 8 pre-dose and at multiple time points (up to 24 hours) post-dose ]
  2. Maximum Observed Plasma Concentration (Cmax) of H3B-6527 [ Time Frame: Escalation, Cycle 1 (21-day cycles): Days 1 and 8 pre-dose and at multiple time points (up to 24 hours) post-dose; Expansion, Cycle 1 (21-day cycles): Days 8 pre-dose and at multiple time points (up to 24 hours) post-dos ]
  3. Time of Maximum Observed Plasma Concentration (tmax) of H3B-6527 [ Time Frame: Escalation, Cycle 1 (21-day cycles): Days 1 and 8 pre-dose and at multiple time points (up to 24 hours) post-dose; Expansion, Cycle 1 (21-day cycles): Days 8 pre-dose and at multiple time points (up to 24 hours) post-dose ]
  4. Objective Response Rate (ORR) [ Time Frame: Escalation and Expansion up to approximately 36 months ]
  5. Duration of Response (DOR) [ Time Frame: Escalation and Expansion up to approximately 36 months ]
  6. Progression-free Survival (PFS) [ Time Frame: Escalation and Expansion up to approximately 36 months ]
  7. Overall Survival (OS) [ Time Frame: Escalation and Expansion up to approximately 36 months ]
  8. Time to Response [ Time Frame: Escalation and Expansion up to approximately 36 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Participants with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC).
  2. Must have received at least one prior standard-of-care therapy or declined such therapy.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  4. Must be willing to undergo a biopsy prior to treatment and on Cycle 2 Day 1 (Part 2 only).
  5. Adequate bone marrow and organ function.

Exclusion criteria:

  1. Uncontrolled significant active infections, except Hepatitis B (HBV) or Hepatitis C (HCV).
  2. Known human immunodeficiency virus (HIV) infection.
  3. Presence of gastric or esophageal varices requiring active treatment.
  4. Previous treatment with selective FGF19-FGFR4 targeted therapy.
  5. Females of childbearing potential, or males who have not had a successful vasectomy, who are unable or unwilling to follow adequate contraceptive measures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834780


Contacts
Contact: Eisai Medical Information 1-888-274-2378

  Show 25 Study Locations
Sponsors and Collaborators
H3 Biomedicine Inc.
Eisai Inc.

Responsible Party: H3 Biomedicine Inc.
ClinicalTrials.gov Identifier: NCT02834780     History of Changes
Other Study ID Numbers: H3B-6527-G000-101
2016-001915-19 ( EudraCT Number )
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Eisai Inc. ( H3 Biomedicine Inc. ):
Advanced Hepatocellular Carcinoma
H3B-6527
Intrahepatic Cholangiocarcinoma
FGFR4
FGF19

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Cholangiocarcinoma
Bile Duct Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases