Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306456
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-29
Brief Title:
A Phase IbII Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC
Sponsor:
Suzhou Genhouse Bio Co Ltd
Organization:
Suzhou Genhouse Bio Co Ltd
Study Overview
Official Title:
A Phase IbII Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of Oral Administration of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With Advanced NSCLC With EGFR Mutations
Status:
RECRUITING
Status Verified Date:
2024-02
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 study including phase Ib phase IIa and phase IIb aims to evaluate the safety tolerability PK profile efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations
Detailed Description:
Phase Ib Classic 33 design used for Phase 1b to select the putative RDEs Four dose groups are preset in phase Ib of this study which including QD groups and BIW groups Subjects will be enrolled in parallel cross into the group
Phase IIa Two cohorts are preset in this stage Cohort 1 GH21 RDE1 QD Osimertinib 80 mg QD Cohort 2 GH21 RDE2 D1D2-BIW Osimertinib 80 mg QD Cohort 1 and Cohort 2 are enrolled in parallel
Phase IIb Phase IIb preset 1 cohort The investigator and sponsor will comprehensively evaluate safety efficacy and PK data from Phases Ib and IIa to determine the dose level for Phase IIb
Phase IIa Two cohorts are preset in this stage Cohort 1 GH21 RDE1 QD Osimertinib 80 mg QD Cohort 2 GH21 RDE2 D1D2-BIW Osimertinib 80 mg QD Cohort 1 and Cohort 2 are enrolled in parallel
Phase IIb Phase IIb preset 1 cohort The investigator and sponsor will comprehensively evaluate safety efficacy and PK data from Phases Ib and IIa to determine the dose level for Phase IIb
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