Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516926
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
SHR-4602 for Injection in Subjects With HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Randomized Multi-center Phase II Clinical Study of SHR-4602 for Injection in Subjects With HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This is an open-label randomized multi-center phase II study to evaluate the safety tolerability PK and efficacy of SHR-4602 monotherapy in subjects with HER2-expressing or -mutated unresectable or metastatic solid tumors
During the study a safety monitoring committee SMC consisting of the principal investigator sponsor representative etc will be established to review data from the study regarding safety PK efficacy etc The SMC will make decisions on study-related issues
The study includes a screening period begins when the informed consent form ICF is signed and ends at the first dose a treatment period from the first dose to the last dose and a follow-up period end-of-treatment safety follow-up
During the study a safety monitoring committee SMC consisting of the principal investigator sponsor representative etc will be established to review data from the study regarding safety PK efficacy etc The SMC will make decisions on study-related issues
The study includes a screening period begins when the informed consent form ICF is signed and ends at the first dose a treatment period from the first dose to the last dose and a follow-up period end-of-treatment safety follow-up
Detailed Description:
None
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