Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394414
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-23
Brief Title:
A Phase 1 Study to Evaluate the Safety Efficacy and Pharmacokinetics of YL201 in 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 Study to Evaluate the Safety Efficacy and Pharmacokinetics of YL201 in Combination With Serplulimab With or Without Platinum-based Chemotherapy in Selected Subjects 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 phase 1 multicenter open-label stydy to Evaluate the Safety Efficacy and Pharmacokinetics of YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy in Selected Subjects with Advanced Solid Tumors conducted in China The study will include 2 parts a dose escalation part Part 1 followed by a cohort expansion part Part 2
Part 1 will estimate the safety tolerability and MTDREDs of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors
Part 2 will estimate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors
Part 1 will estimate the safety tolerability and MTDREDs of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors
Part 2 will estimate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors
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