Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435455
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-05-24
Brief Title:
GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors
Sponsor:
Suzhou Genhouse Bio Co Ltd
Organization:
Suzhou Genhouse Bio Co Ltd
Study Overview
Official Title:
A Phase IbII Clinical Study Evaluating the Safety Tolerability Pharmacokinetics and Efficacy of GH21 Capsule Combined With D-1553 Tablets in Patients With Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 s a multi-center open-label phase IbII study to evaluate the safety tolerability pharmacokinetics and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation
Detailed Description:
This study includes 2 parts dose escalationPhase Ib and dose expansion Phase II The objective of the dose escalation part is to evaluate the safety tolerability and pharmacokinetics of GH21 in combination with D-1553 in patients with advanced solid tumors harboring KRAS G12C mutation and to determine the RP2D for the combination therapy In the dose expansion part preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS G12C mutation
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