Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428331
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-20
Brief Title:
A Study of SKB518 in Patients With Advanced Solid Tumors
Sponsor:
Sichuan Kelun Pharmaceutical Research Institute Co Ltd
Organization:
Sichuan Kelun Pharmaceutical Research Institute Co Ltd
Study Overview
Official Title:
A Phase 1 Multicenter Open-label First-In-Human Study to Evaluate the Safety Tolerability Pharmacokinetics and Antitumor Activity of SKB518 in Subjects With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 is a first-in-human FIH phase 1 multicenter open-label dose-escalation study of SKB518 to evaluate the safety tolerability PK immunogenicity and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsedrefractory to standard therapies or for which no effective standard therapy is available
Detailed Description:
This is a first-in-human FIH phase 1 multicenter open-label dose-escalation study of SKB518 to evaluate the safety tolerability PK immunogenicity and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsedrefractory to standard therapies or for which no effective standard therapy is available Dose escalation and de-escalation decisions are based on the mTPI-2 design and depend on the number of subjects enrolled and the number of DLTs observed at the current dose level
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