Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384352
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-03-26
Brief Title:
A Phase I Study to Evaluate the SafetyTolerability Pharmacokinetics and Efficacy of YL211 in Patients With Advanced Solid Tumors
Sponsor:
MediLink Therapeutics Suzhou Co Ltd
Organization:
MediLink Therapeutics Suzhou Co Ltd
Study Overview
Official Title:
A Phase 1 Multicenter Open-Label First-in-Human Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of YL211 in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-05
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 multicenter open-label Phase 1 study The study will enroll subjects with advanced solid tumors It consists of three parts Part 1 is dose-escalation part In part 1 the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined
Part 2 is backfill enrollment part We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the REDs of YL211
Part 3 is dose-expansion part In this part we will further evaluate the safety and efficacy of YL211 at the MTDREDs in patients with selected advanced solid tumors YL211 will be administered intravenously IV until criteria of treatment discontinuation are met
Part 2 is backfill enrollment part We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the REDs of YL211
Part 3 is dose-expansion part In this part we will further evaluate the safety and efficacy of YL211 at the MTDREDs in patients with selected advanced solid tumors YL211 will be administered intravenously IV until criteria of treatment discontinuation are met
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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