Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616766
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
A Phase 12 Open-label Multicenter FIH Study to Evaluate Safety Tolerability PK and Anti-tumor Activity of YH42946
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 12 Open-label Multicenter FIH Study to Evaluate the Safety Tolerability PK and Anti-tumor Activity of YH42946 in Patients with Locally Advanced or Metastatic Solid Tumors with HER2 Aberration and EGFR Exon 20 Insertion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
The goal of this YH42946-101 is to evaluate the safety Tolerability Pharmacokinetics and anti-tumor activity of YH42946 in patients with locally advanced of metastatic solid tumors with HER2 aberration and EGFR exon 20 insertions
Detailed Description:
YH42946 is a novel orally available tyrosine kinase inhibitor targeting HER2 YH42946 showed potency for diverse HER2 aberrations including HER2 overexpression amplification or mutation as well as EGFR Ex20ins
This is a Phase 12 open-label multicenter first-in-human study of YH42946 The study has 2 parts The first part is dose escalation part to identify the maximum tolerated dose The second part is dose expansion part to select 2 doses for RD selection at the first cohort after then RD will be determined to ensure its efficacy Several independent cohorts are planned
This is a Phase 12 open-label multicenter first-in-human study of YH42946 The study has 2 parts The first part is dose escalation part to identify the maximum tolerated dose The second part is dose expansion part to select 2 doses for RD selection at the first cohort after then RD will be determined to ensure its efficacy Several independent cohorts are planned
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