Ignite Creation Date:
2024-05-06 @ 8:51 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02834780
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2016-07-13
Brief Title:
Phase 1 Study to Evaluate the Safety Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
Sponsor:
H3 Biomedicine Inc
Organization:
Eisai Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-001915-19 | EUDRACT_NUMBER | None | None |