Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05666635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-12-28
First Post:
2022-11-10
Brief Title:
Study of LTC004 in Subjects With Advanced Malignant Tumors
Sponsor:
Letolab
Organization:
Letolab
Study Overview
Official Title:
A Phase I Clinical Trial to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of LTC004 in Patients With Advanced or Metastatic Malignancies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
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 was a multicenter open multi-cohort PHASE I study consisting of 2 phases Phase Ia Phase Ia dose escalation and Phase Ib Phase Ib multi-cohort expansion The objective of this study was to evaluate safety tolerability pharmacokinetic Pharmacodynamics and biological characteristics and initial efficacy in advanced malignant tumors
Detailed Description:
Phase I dose escalation phaseThis study predicted a total of 8 dose groups 3 15 45 90 180270360 and 450 ugkg
Phase Ib expansion phase This phase is the multi-cohort indication expansion phase Based on the data obtained in phase I chose an appropriate dose continue to explore multi-cohort indications
Phase Ib expansion phase This phase is the multi-cohort indication expansion phase Based on the data obtained in phase I chose an appropriate dose continue to explore multi-cohort indications
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