Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232863
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2024-01-19
Brief Title:
A Study of BH009 in Head and Neck Squamous Cell Carcinoma and Ovarian Cancer
Sponsor:
Zhuhai Beihai Biotech Co Ltd
Organization:
Zhuhai Beihai Biotech Co Ltd
Study Overview
Official Title:
A Phase I Study To Evaluate The Safety Tolerability and Pharmacokinetics Of BH009 In Patients With Advanced Head And Neck Squamous Non-nasopharyngeal And Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-01
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:
This study will assess the safety and tolerability and pharmacokinetics of BH009 in patients with advanced head and neck squamous non-nasopharyngeal and ovarian cancer
Detailed Description:
This is a multicenter open label phase I clinical study to evaluate the safety tolerability and pharmacokinetic profile of BH009 in patients with advanced squamous head and neck cancer non-nasopharyngeal and ovarian cancer and to initially explore its clinical effectiveness This study will use a 33 dose escalation design to determine the maximum tolerated dose MTD and the recommended phase 2 dose RP2D of BH009
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| CTR20230004 | OTHER | NMPA | None |