Trials / Completed
CompletedNCT02834780
Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- H3 Biomedicine Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Advanced Hepatocellular Carcinoma
- Hepatocellular Carcinoma
- Liver Cancer
- Liver Neoplasms
- Hepatic Cancer
- Hepatic Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | H3B-6527 | H3B-6527 by mouth once or twice daily at specified doses. |
Timeline
- Start date
- 2016-12-28
- Primary completion
- 2022-02-23
- Completion
- 2022-02-23
- First posted
- 2016-07-15
- Last updated
- 2023-11-13
- Results posted
- 2023-11-13
Locations
44 sites across 11 countries: United States, Belgium, Canada, France, Italy, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02834780. Inclusion in this directory is not an endorsement.