Phase III Study of TGRX-814 to Evaluate Safety, Dosage, and Early Effectiveness in Adults With Blood Cancers Including Lymphoma and Leukemia

What this Trial Is About

Researchers are evaluating TGRX-814, an investigational oral drug, in patients with blood cancers including non-Hodgkin lymphoma, acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes. This early-phase study aims to assess the safety, how the drug moves through the body, and initial signs of how it might work. The study focuses on finding the highest safe dose and the recommended dose for future research in these conditions. The study involves a dose escalation phase where participants receive TGRX-814 tablets once daily by mouth at increasing dose levels to identify the optimal dose. It also includes a dose expansion phase and combination therapy studies to further evaluate safety and preliminary effectiveness. These phases help determine the best way to use TGRX-814 alone and with other treatments. Participants will have regular evaluations including monitoring for side effects, laboratory tests, and disease assessments at scheduled intervals during treatment cycles of 28 days. Researchers will track responses such as complete and partial remission as well as drug levels in the blood. Follow-up visits will continue after treatment to assess safety and long-term outcomes. Participation may last around one year or more depending on the study phase and disease status.

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