Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-28 @ 10:46 AM
Study NCT ID:
NCT06322095
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors
Sponsor:
Suzhou Genhouse Bio Co., Ltd.
Organization:
Study Overview
Official Title:
An Open Exploratory Study to Evaluate The Preliminary Efficacy of GH21 Combined With Primary Targeting or Immunotherapy in Patients With Advanced Solid Tumors Which Targeted or Immunotherapy Has Progressed
Status:
RECRUITING
Status Verified Date:
2024-03
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 is aim to evaluate the preliminary efficacy of GH21 combined with previous target therapy or immunotherapy in patients with advanced solid tumors.
Detailed Description:
This study preset two dose groups, dose group 1 is GH21 15 mg (BIW, D1D2) combined with ALK inhibitor, or MET inhibitor, or BRAF inhibitor +MEK inhibitor, or PD-1 inhibitor, or EGFR monoantibody, or other drugs such as FGFR inhibitor, and it is planned to enroll up to 36 subjects. Dose group 2 was GH21 6 mg (QD) combined with ALK inhibitor, or MET inhibitor, or BRAF inhibitor +MEK inhibitor, or PD-1 inhibitor, or EGFR monoclonal antibody, or other drugs such as FGFR inhibitor, and was planned to enroll up to 36 subjects.
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?: