Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 2:11 PM
Study NCT ID:
NCT06022250
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2023-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
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 is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK),Pharmacodynamic characteristics, immunogenicity and antitumor activity of JS207 in patients with advanced malignant tumor. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics.
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?: