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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02834780
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : January 6, 2020
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc. ( H3 Biomedicine Inc. )

Study Description
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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 Hepatocellular Carcinoma Liver Cancer Liver Neoplasms Hepatic Cancer Hepatic Carcinoma Drug: H3B-6527 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: N/A
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
Actual Study Start Date : July 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

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


Outcome Measures
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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 within 30 days after last study drug dose (up to 48 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 predose and at multiple time points (up to 24 hours) postdose, Day 15 (0 hours); Expansion, Cycle 1 (21-day cycles): Days 8 predose and at multiple time points (up to 24 hours) postdose, Day 15 (0 hours) ]
  2. Maximum Observed Plasma Concentration (Cmax) of H3B-6527 [ Time Frame: Escalation, Cycle 1 (21-day cycles): Days 1 and 8 predose and at multiple time points (up to 24 hours) postdose, Day 15 (0 hours); Expansion, Cycle 1 (21-day cycles): Days 8 predose and at multiple time points (up to 24 hours) postdose, Day 15 (0 hours) ]
  3. Time of Maximum Observed Plasma Concentration (tmax) of H3B-6527 [ Time Frame: Escalation, Cycle 1 (21-day cycles): Days 1 and 8 predose and at multiple time points (up to 24 hours) postdose, Day 15 (0 hours); Expansion, Cycle 1 (21-day cycles): Days 8 predose and at multiple time points (up to 24 hours) postdose, Day 15 (0 hours) ]
  4. Objective Response Rate (ORR) [ Time Frame: Escalation and Expansion up to approximately 48 months ]
  5. Duration of Response (DOR) [ Time Frame: Escalation and Expansion up to approximately 48 months ]
  6. Progression-free Survival (PFS) [ Time Frame: Escalation and Expansion up to approximately 48 months ]
  7. Overall Survival (OS) [ Time Frame: Escalation and Expansion up to approximately 48 months ]
  8. Time to Response [ Time Frame: Escalation and Expansion up to approximately 48 months ]

Eligibility Criteria
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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.
  2. Must have had at least one prior standard-of-care therapy, unless contraindicated.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  4. Must be willing to undergo a biopsy up to 8 weeks before administration of H3B-6527 on Cycle 1 Day 1 for part 2 (dose expansion).
  5. Adequate bone marrow and organ function.

Exclusion criteria:

  1. Uncontrolled significant active infections, except hepatitis B virus (HBV) or hepatitis C virus (HCV).
  2. Known human immunodeficiency virus infection.
  3. Presence of gastric or esophageal varices requiring active treatment.
  4. Previous treatment with a 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.
  6. Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
Contacts and Locations
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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
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Contact: Eisai Medical Information 1-888-274-2378 esi_oncmedinfo@eisai.com

Locations
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Sponsors and Collaborators
H3 Biomedicine Inc.
Eisai Inc.
More Information
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Responsible Party: H3 Biomedicine Inc.
ClinicalTrials.gov Identifier: NCT02834780    
Other Study ID Numbers: H3B-6527-G000-101
2016-001915-19 ( EudraCT Number )
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc. ( H3 Biomedicine Inc. ):
Advanced Hepatocellular Carcinoma
H3B-6527
Fibroblast growth factor receptor 4 (FGFR4)
Fibroblast growth factor 19 (FGF19)
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases