Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06057922
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-09-21
Brief Title:
A Study YL201 in Patients With Selected Advanced Solid Tumors
Sponsor:
MediLink Therapeutics Suzhou Co Ltd
Organization:
MediLink Therapeutics Suzhou Co Ltd
Study Overview
Official Title:
A Multicenter Open-Label Phase 12 Study to Evaluate the Safety Efficacy and Pharmacokinetics of YL201 in Patients With Selected Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-12
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 12 Study to Evaluate the Safety Efficacy and Pharmacokinetics of YL201 in Patients with Selected Advanced Solid Tumors The study will include 2 parts Phase 1 dose expansion stage Part 1 followed by a Phase 2 stage with expanded sample size Part 2
Part 1 will estimate the RP2D in dose expansion cohorts of patients with not linited to non-small cell lung cancer NSCLC small cell lung cancer SCLC nasopharyngeal carcinoma NPC esophageal squamous cell carcinoma ESCC metastatic castration-resistant prostate cancer mCRPC etc
Part 2 will include patients with selected advanced solid tumor types enrolled at the RP2D to further assess the efficacy and safety of YL201
Part 1 will estimate the RP2D in dose expansion cohorts of patients with not linited to non-small cell lung cancer NSCLC small cell lung cancer SCLC nasopharyngeal carcinoma NPC esophageal squamous cell carcinoma ESCC metastatic castration-resistant prostate cancer mCRPC etc
Part 2 will include patients with selected advanced solid tumor types enrolled at the RP2D to further assess the efficacy and safety of YL201
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