Clinical Trials /

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

NCT02834780

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.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: H3B-6527-G000-101
  • SECONDARY ID: 2016-001915-19
  • NCT ID: NCT02834780

Conditions

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

Interventions

DrugSynonymsArms
H3B-6527H3B-6527 (escalation and expansion)

Purpose

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 Arms

NameTypeDescriptionInterventions
H3B-6527 (escalation and expansion)ExperimentalHepatocellular Carcinoma
  • H3B-6527

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Dose-limiting Toxicities (DLTs)
Time Frame:Escalation Cycle 1 (21 days)
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure:Objective Response Rate (ORR)
Time Frame:Escalation and Expansion up to approximately 48 months
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:Escalation and Expansion up to approximately 48 months
Safety Issue:
Description:
Measure:Progression-free Survival (PFS)
Time Frame:Escalation and Expansion up to approximately 48 months
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:Escalation and Expansion up to approximately 48 months
Safety Issue:
Description:
Measure:Time to Response
Time Frame:Escalation and Expansion up to approximately 48 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:H3 Biomedicine Inc.

Trial Keywords

  • Advanced Hepatocellular Carcinoma
  • H3B-6527
  • Fibroblast growth factor receptor 4 (FGFR4)
  • Fibroblast growth factor 19 (FGF19)

Last Updated

October 19, 2020