Phase 1
Completed N=128
Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
Source: ClinicalTrials.gov NCT02834780 ↗Enrolled (actual)
128
Serious AEs
34.4%
Results posted
Nov 2023
Primary outcomePrimary: Part 1, Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1, Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
3; 3; 4; 10; 3; 7 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Vital Sign Parameters |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 Through the Last Measurable Point (AUC0-t) of H3B-6527 |
68.9; 173; 1631; 850; 1115; 400 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of H3B-6527 |
20.3; 74.5; 395; 225; 182; 136 | — |
| SECONDARY Time of Maximum Observed Plasma Concentration (Tmax) of H3B-6527 |
2.00; 1.00; 4.00; 2.02; 6.00; 1.00 | — |
| SECONDARY Part 2, Dose Expansion Phase: Objective Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1 |
5.6; 0.0 | — |
| SECONDARY Part 2, Dose Expansion Phase: Duration of Response (DOR) Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1 |
NA | — |
| SECONDARY Part 2, Dose Expansion Phase: Progression-free Survival (PFS) Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1 |
2.6; 3.0 | — |
| SECONDARY Part 2, Dose Expansion Phase: Overall Survival (OS) |
9.5; 7.7 | — |
| SECONDARY Part 2, Dose Expansion Phase: Time to Response (TTR) Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1 |
NA | — |
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.
Data sourced from ClinicalTrials.gov (NCT02834780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.