NCT06550713

A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies

Phase I Clinical Trial Protocol for Tolerability and Pharmacokinetics of TQB3455 Tablets in Patients With Hematological Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Myeloid Leukemia (AML)
• Myelodysplastic Syndrome (MDS)

Interventions

Type	Name	Description
DRUG	TQB3455 tablet+Azacitidine for Injection	TQB3455 is a selective IDH2 mutant enzyme inhibitor. Azacitidine for injection is a cytosine nucleoside drug that is used for demethylation therapy.

Timeline

• Start date: 2019-10-22
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-08-13
• Last updated: 2024-08-13

Locations

7 sites across 1 country: China