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Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
NCT02834780 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG H3B-6527
Study Locations (20)
California
- USC/Norris Comprehensive Cancer Center — Los Angeles
- Hoag Memorial Hospital Presbyterian — Newport Beach
- UC Irvine Medical Center — Orange
- UCLA Medical Center — Santa Monica
Texas
- Simmons Comprehensive Cancer Center — Dallas
- University of Texas Southwestern Medical Center — Dallas
Other
- Universitair Ziekenhuis Gent — Ghent
- Institut Bergonié — Bordeaux
District of Columbia
- Georgetown Unversity Lombardi Comprehensive Cancer Center — Washington D.C.
Illinois
- Northwestern Unversity — Chicago
Massachusetts
- Massachusetts General Hospital — Boston
Michigan
- Barbara Ann Karmanos Cancer Institute — Detroit
New Jersey
- John theurer Cancer Center at Hackensack University Medical Center — Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2016-12-28 |
| Est. Completion | 2022-02-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02834780
The ClinicalTrials.gov registry entry for NCT02834780 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H3 Biomedicine, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 1 intervention — of which H3B-6527 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02834780 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Texas, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02834780 about?
NCT02834780 is a clinical study titled "Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma". 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.
What is the current status of trial NCT02834780?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2016-12-28. Estimated completion is 2022-02-23.
What conditions does trial NCT02834780 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Liver Cancer, Advanced Hepatocellular Carcinoma, Liver Neoplasms, Hepatic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02834780?
The interventions under investigation include: H3B-6527 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02834780?
This trial is sponsored by H3 Biomedicine, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02834780 being conducted?
This trial has 20 study locations across California, District of Columbia, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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