Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548217
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Uncontrolled Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter open-label uncontrolled phase I study to evaluate the tolerability safety pharmacokinetics and efficacy of ONO-4538HSC administered subcutaneously in participants with advanced or metastatic solid tumors This study consists of the tolerability confirmation part to determine the recommended dose for Japanese participants by evaluating the DLTs and the expansion part to evaluate the safety and pharmacokinetics and to explore the efficacy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None