Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT07073534
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-18
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors
Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
Phase I/II Clinical Study on the Tolerability, Safety and Efficacy of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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 study is an open, multicenter phase I/II clinical study. The entire study is divided into three stages: dose escalation, dose expansion, and efficacy expansion. Objective: To evaluate the objective response rate (ORR), safety and tolerability of the combination of SHR-1501 and adibelizumab in the treatment of advanced malignant tumors, and to provide the recommended dose (RP2D) for subsequent clinical studies.
Detailed Description:
None
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?: