RecruitingPhase 1Phase 2NCT06206174

TGRX-814 Chinese Phase I/II in Patients With Hematological Malignancies

A Single-arm, Open-label, Dose Escalation and Expansion Phase I/II Study Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-814 Monotherapy and Combination Therapy in Patients With Hematological Malignancies


Sponsor

Shenzhen TargetRx Co., Ltd.

Enrollment

30 participants

Start Date

Mar 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this single- arm, open-label, dose escalation and dose expansion phase I/II 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called TGRX-814 in patients with certain blood cancers that have come back or stopped responding to prior treatments. The trial explores safe doses and early signs of effectiveness. **You may be eligible if...** - You are 18 or older - You have been diagnosed with non-Hodgkin lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, or a bone marrow disorder called MDS - You are in adequate health with acceptable blood counts and organ function **You may NOT be eligible if...** - You have active infections or serious uncontrolled medical conditions - You have received certain prior treatments that would interfere with the drug - Your cancer has spread to the brain in an active, uncontrolled way Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTGRX-814

Participants are given TGRX-814 tablets for oral, once daily administration at one of the dose levels as pre-determined for the dose escalation sequence.


Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

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NCT06206174


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