Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384248
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-22
Brief Title:
Phase II Clinical Study of LTC004 in Patients With Advanced Sarcoma
Sponsor:
Letolab
Organization:
Letolab
Study Overview
Official Title:
An Open Single-Arm Phase II Clinical Study Evaluating the Efficacy and Safety of LTC004 Alone in Patients With Locally Advanced or Metastatic Sarcoma Who Have Failed Standard Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 II clinical study to evaluate the safety tolerability and preliminary antitumor activity of LTC004 in patients with locally advanced or metastatic sarcomaEnrollment of 10 evaluable subjects in Phase I If 2 subjects experience objective remission or SD lasting 12 weeks proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004
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?:
None