Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417008
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-12
Brief Title:
A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer
Sponsor:
Hansoh BioMedical RD Company
Organization:
Hansoh BioMedical RD Company
Study Overview
Official Title:
A Phase IbIII Clinical Study to Evaluate the Safety Efficacy Pharmacokinetics and Immunogenicity of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer
Status:
NOT_YET_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:
HS-20117 is a fully-human EGFR-MET immunoglobulin G1IgG1-like bispecific antibody The purpose of this study is to assess the safety efficacy pharmacokinetics and immunogenicity of HS-20117 combined with Aumolertinib in participants with epidermal growth factor receptor EGFR mutation Exon 19 deletions Exon 19del or Exon 21 L858R substitution positive locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC
Detailed Description:
This is a multicenter Phase IbIII clinical study evaluating the safety efficacy pharmacokinetics PK and immunogenicity of HS-20117 in combination with aumolertinib in subjects with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC The study is divided into two phases Phase Ib a dose expansion study and Phase III a confirmatory study In the dose expansion phase Phase Ib HS-20117 will first be studied in combination with the standard dose of aumolertinib to assess the efficacy safety tolerability PK profile and immunogenicity of HS-20117 in combination with aumolertinib in the target population as well as to determine the recommended Phase III dose RP3D Following confirmation of the safety and efficacy of HS-20117 in combination with aumolertinib and RP3D in Phase Ib a randomized active-controlled open-label multicenter Phase III study will be initiated to assess the efficacy and safety of HS-20117 in combination with aumolertinib versus aumolertinib in the target population in the confirmatory study phase
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