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drugset / Trial / NCT06550713

A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies

NCT06550713 ↗

Phase 1 Recruiting 100 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This study is a clinical trial to evaluate the tolerability and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies. TQB3455 is an isocitrate dehydrogenase 2(IDH2) inhibitor . This project is divided into two stages. The first stage aims to evaluate the safety and tolerability of single or multiple oral administration of TQB3455 tablets in subjects with malignant hematological tumors. The second phase aims to evaluate the efficacy and safety of TQB3455 tablets alone or in combination with azacitidine in subjects with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Timeline

Start
2019-10-22
Primary completion
2025-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified — Subcutaneous
Subject TQB3455 Small molecule — Oral

Indications

acute myeloid leukemia myelodysplastic syndrome