Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT05867303
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-16
First Post:
2023-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A RC198 Study in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
Sponsor:
RemeGen Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Immunogenetic and Efficacy of RC198 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
Safety study of RC198 in Subjects with Solid Tumors.
Detailed Description:
This is a Phase 1, first-in-human, open-label study to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RC198 in subjects with locally advanced unresectable or metastatic solid tumors for whom standard therapy does not exist, is no longer effective, or is not acceptable.
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?: