Viewing Study NCT06553339



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