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 :
Completed
First Posted : July 15, 2016
Last Update Posted : April 6, 2022
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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 Type : | Interventional (Clinical Trial) |
Actual 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 31, 2016 |
Actual Primary Completion Date : | February 24, 2022 |
Actual Study Completion Date : | February 24, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: H3B-6527 (escalation and expansion)
Hepatocellular Carcinoma
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Drug: H3B-6527
H3B-6527 by mouth once or twice daily at specified doses. |
- Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: Escalation Cycle 1 (21 days) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- Objective Response Rate (ORR) [ Time Frame: Escalation and Expansion up to approximately 48 months ]
- Duration of Response (DOR) [ Time Frame: Escalation and Expansion up to approximately 48 months ]
- Progression-free Survival (PFS) [ Time Frame: Escalation and Expansion up to approximately 48 months ]
- Overall Survival (OS) [ Time Frame: Escalation and Expansion up to approximately 48 months ]
- Time to Response [ Time Frame: Escalation and Expansion up to approximately 48 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 |
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.

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

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: | April 6, 2022 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Advanced Hepatocellular Carcinoma H3B-6527 Fibroblast growth factor receptor 4 (FGFR4) Fibroblast growth factor 19 (FGF19) |
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 |