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

Primary Purpose

Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma, Liver Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
H3B-6527
Sponsored by
H3 Biomedicine Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma focused on measuring Advanced Hepatocellular Carcinoma, H3B-6527, Fibroblast growth factor receptor 4 (FGFR4), Fibroblast growth factor 19 (FGF19)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC/Norris Comprehensive Cancer Center
  • Hoag Memorial Hospital Presbyterian
  • UC Irvine Medical Center
  • UCLA Medical Center
  • Georgetown Unversity Lombardi Comprehensive Cancer Center
  • Northwestern Unversity
  • Massachusetts General Hospital
  • Barbara Ann Karmanos Cancer Institute
  • John theurer Cancer Center at Hackensack University Medical Center
  • Duke University Cancer Center
  • University of Cincinnati Cancer Institute
  • University of Pennsylsvania - Perelman Cancer Center for Advanced Medicine
  • Simmons Comprehensive Cancer Center
  • University of Texas Southwestern Medical Center
  • McGuire VA Medical Center
  • UCL Cliniques universitaires Saint-Luc
  • Universitair Ziekenhuis Gent
  • Cross Cancer Institute
  • Jurvanski Cancer Center
  • Institut Bergonié
  • Centre Oscar Lambret
  • Hôpital Haut-Lévêque - CHU de Bordeaux
  • Centre Eugène Marquis
  • IRCCS Istituto Scientifico Romagnolo per lo studio e la cura dei tumori - U.O. di Oncologia Medica
  • IRCCS Ospedale San Raffaele S.r.l. - PPDS
  • Azienda Ospedaliero Universitaria - Policlinico di Modena
  • Asan Medical Center
  • Altay Regional Oncology Center
  • Russian Oncology Research Center n a N N Blokhin
  • Omsk Regional Oncology Center
  • Railway Clinical Hospital JSC RZhD
  • City Clinical Oncology Dispensary
  • National University Cancer Insitute
  • Hospital Universitario Marques de Valdecilla
  • Clínica Universidad de Navarra
  • Hospital Universitario de Badajoz
  • Hospital Universitario Vall d'Hebron
  • General Universitario Gregorio Maranon
  • START Madrid FJD, Hospital Universitario Fundacion Jimenez Diaz
  • Hospital Universitario HM Sanchinarro
  • Hospital Universitario Virgen del Rocio
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • Sarah Cannon Research Institute UK - SCRI - PPDS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

H3B-6527 (escalation and expansion)

Arm Description

Hepatocellular Carcinoma

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2016
Last Updated
April 5, 2022
Sponsor
H3 Biomedicine Inc.
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02834780
Brief Title
Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2016 (Actual)
Primary Completion Date
February 24, 2022 (Actual)
Study Completion Date
February 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H3 Biomedicine Inc.
Collaborators
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasms, Hepatic Cancer, Hepatic Carcinoma
Keywords
Advanced Hepatocellular Carcinoma, H3B-6527, Fibroblast growth factor receptor 4 (FGFR4), Fibroblast growth factor 19 (FGF19)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H3B-6527 (escalation and expansion)
Arm Type
Experimental
Arm Description
Hepatocellular Carcinoma
Intervention Type
Drug
Intervention Name(s)
H3B-6527
Intervention Description
H3B-6527 by mouth once or twice daily at specified doses.
Primary Outcome Measure Information:
Title
Number of Participants with Dose-limiting Toxicities (DLTs)
Time Frame
Escalation Cycle 1 (21 days)
Title
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 Measure Information:
Title
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)
Title
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)
Title
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)
Title
Objective Response Rate (ORR)
Time Frame
Escalation and Expansion up to approximately 48 months
Title
Duration of Response (DOR)
Time Frame
Escalation and Expansion up to approximately 48 months
Title
Progression-free Survival (PFS)
Time Frame
Escalation and Expansion up to approximately 48 months
Title
Overall Survival (OS)
Time Frame
Escalation and Expansion up to approximately 48 months
Title
Time to Response
Time Frame
Escalation and Expansion up to approximately 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participants with hepatocellular carcinoma. Must have had at least one prior standard-of-care therapy, unless contraindicated. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 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). Adequate bone marrow and organ function. Exclusion criteria: Uncontrolled significant active infections, except hepatitis B virus (HBV) or hepatitis C virus (HCV). Known human immunodeficiency virus infection. Presence of gastric or esophageal varices requiring active treatment. Previous treatment with a selective FGF19-FGFR4 targeted therapy. Females of childbearing potential, or males who have not had a successful vasectomy, who are unable or unwilling to follow adequate contraceptive measures. Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Facility Name
UCLA Medical Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Georgetown Unversity Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Northwestern Unversity
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
John theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Duke University Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati Cancer Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Pennsylsvania - Perelman Cancer Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Simmons Comprehensive Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
UCL Cliniques universitaires Saint-Luc
City
Woluwe-Saint-Lambert
State/Province
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G IZ2
Country
Canada
Facility Name
Jurvanski Cancer Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hôpital Haut-Lévêque - CHU de Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
IRCCS Istituto Scientifico Romagnolo per lo studio e la cura dei tumori - U.O. di Oncologia Medica
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele S.r.l. - PPDS
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria - Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Altay Regional Oncology Center
City
Barnaul
State/Province
Altay, Re
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Russian Oncology Research Center n a N N Blokhin
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Omsk Regional Oncology Center
City
Omsk
ZIP/Postal Code
644046
Country
Russian Federation
Facility Name
Railway Clinical Hospital JSC RZhD
City
Saint Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
City Clinical Oncology Dispensary
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
National University Cancer Insitute
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario de Badajoz
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
START Madrid FJD, Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Sarah Cannon Research Institute UK - SCRI - PPDS
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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