Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553339
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
A Study of HS-10516 in Patients With VHL Syndrome Associated Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Study of HS-10516 in Patients With VHL Syndrome Associated Tumorsto Investigate Safety Tolerance Pharmacokinetic and Efficacy
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The aim of the Phase Ia portion is to identify the maximum tolerated dose or maximum acceptable dose MTDMAD of HS-10516 The phase Ib portion will evaluate the preliminary efficacy of HS-10516 in patients with VHL Syndrome Associated Tumors
Detailed Description:
This is a Phase IaIb open label multicenter study of HS-10516 in Chinese patients aged 18 years or older with VHL Syndrome Associated Tumors HS-10516 as a single agent is administrated orally once daily The aim of phase Ia a dose escalation study is to identify the MTDMAD of HS-10516 The goal of Phase Ib a dose expansion study is to evaluate the safety pharmacokinetics and antitumor efficacy of HS-10516
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