Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-02-01 @ 10:04 AM
Study NCT ID:
NCT05666635
Status:
UNKNOWN
Last Update Posted:
2022-12-28
First Post:
2022-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of LTC004 in Subjects With Advanced Malignant Tumors
Sponsor:
Letolab
Organization:
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:
UNKNOWN
Status Verified Date:
2022-12
Last Known Status:
NOT_YET_RECRUITING
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 phase：This study predicted a total of 8 dose groups, 3, 15, 45, 90, 180，270，360 and 450 ug/kg.
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:
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?: