Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621563
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Phase Ib Trial of HS-20117 in Combination with Other Drugs in Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety Tolerability Efficacy Pharmacokinetics Profile and Immunogenicity of HS-20117 in Combination with Other Drugs in Advanced Solid Tumors a Phase Ib Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HS-20117
Brief Summary:
HS-20117 is a fully-human EGFR-MET immunoglobulin G1IgG1-like bispecific antibody The purpose of study is to evaluate the safety tolerability efficacy PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors
Detailed Description:
This is a multicenter open-label Phase Ib clinical trial of HS-20117 combination therapies to evaluate the safety tolerability efficacy PK profile and immunogenicity in participants with advanced solid tumors The study includes a dose escalation part and a dose expansion part The dose-escalation study will be performed to evaluate the safety tolerability PK profile immunogenicity and efficacy of HS-20117 combination therapies in participants with advanced solid tumor The subsequent dose-expansion study will be performed to evaluate the efficacy of HS-20117 combination therapies in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations or EGFR classical mutations and RASBRAF V600E wild type CRC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None