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.
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
Drug | Synonyms | Arms |
---|
H3B-6527 | | H3B-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
Name | Type | Description | Interventions |
---|
H3B-6527 (escalation and expansion) | Experimental | Hepatocellular Carcinoma | |
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