Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-29 @ 8:59 AM
Study NCT ID:
NCT06226350
Status:
COMPLETED
Last Update Posted:
2024-01-26
First Post:
2024-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ⅱ Study of F520 in Patients With Cervical Carcinoma
Sponsor:
Shandong New Time Pharmaceutical Co., LTD
Organization:
Study Overview
Official Title:
An Open, Single-arm, Multicenter Phase II Trial of Efficacy and Safety of F520 Monotherapy in the Treatment of Advanced, Persistent, Recurrent, or Metastatic Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2024-01
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 was an open, single-arm, enriched, multicenter Phase II study.
Detailed Description:
The trial was divided into screening period, treatment period and follow-up period. Participants entered the screening period after signing informed consent and met the inclusion criteria. Subjects who did not meet the exclusion criteria were treated with F520 monotherapy, intravenously, at 3mg/kg every 3 weeks until disease progression or intolerable toxicity or withdrawal for other reasons, for a maximum of 2 years.
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?: