Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206174
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-01-04
Brief Title:
TGRX-814 Chinese Phase III in Patients With Hematological Malignancies
Sponsor:
Shenzhen TargetRx Inc
Organization:
Shenzhen TargetRx Inc
Study Overview
Official Title:
A Single-arm Open-label Dose Escalation and Expansion Phase III Study Evaluating Safety Tolerability Pharmacokinetics and Preliminary Efficacy of TGRX-814 Monotherapy and Combination Therapy in Patients With Hematological Malignancies
Status:
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:
The purpose of this single- arm open-label dose escalation and dose expansion phase III study is to evaluate the safety tolerability pharmacokinetic and preliminary efficacy of TGRX-814 in patients with hematological malignancies including non-Hodgkin lymphoma acute myeloid leukemia aute lymphoblastic leukemia and myelodysplastic syndromes
Detailed Description:
This is the first-in-human trial with TGRX-814 which aims to evaluate the safety pharmacokinetic and preliminary efficacy profiles with hematological malignancies The primary purpose of this study is to evaluate the safety profile of TGRX-814 in patients with non-Hodgkin lymphoma and to determine of the maximal tolerated dose MTD and recommended phase II dose RP2D Other purposes of the study include evaluating safety and preliminary efficacy of TGRX-814 monotherapy and combination therapy in patients with other types of hematological malignancies including acute myeloid leukemia aute lymphoblastic leukemia and myelodysplastic syndromes as well as evaluating the pharmacokinetic profile of TGRX-814 The study is a phase III study consisting a monotherapy dose escalation study monotherapy dose expansion study and combination therapy study
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