Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-08 @ 11:02 PM
Study NCT ID:
NCT04947033
Status:
RECRUITING
Last Update Posted:
2023-03-14
First Post:
2021-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating TJ210001 in the Treatment of Subjects With Advanced Solid Tumors
Sponsor:
I-Mab Biopharma US Limited
Organization:
Study Overview
Official Title:
A Phase I Clinical Study Evaluating the Safety, Tolerability, MTD or MAD, PK, PD, and Antitumor Activity of TJ210001(a Fully Human C5aR Monoclonal Antibody) in Subjects With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-03
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:
A phase I clinical study evaluating TJ210001 in the treatment of subjects with advanced solid tumors
Detailed Description:
This study is a phase I clinical study evaluating TJ210001 monotherapy in patients with advanced solid tumors in dose escalation. The overall design of the study is shown in the figure below. The purpose of the TJ210001 single-dose escalation study in subjects with advanced solid tumors is to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and clinically recommended doses of TJ210001 monotherapy.
Study Oversight
Has Oversight DMC:
True
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?: