OncoMatch/Clinical Trials/NCT06550713
A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies
Is NCT06550713 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies TQB3455 tablet+Azacitidine for for acute myeloid leukemia (aml).
Treatment: TQB3455 tablet+Azacitidine for — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: IDH2 mutation
Prior therapy
Cannot have received: bone marrow transplantation
Exception: relapse after bone marrow transplantation
Subjects who experience relapse after bone marrow transplantation
Cannot have received: systemic anti-tumor therapy
Exception: within 3 weeks prior to the use of the investigational drug
Subjects who have received systemic anti-tumor therapy or radiation therapy within 3 weeks prior to the use of the investigational drug
Cannot have received: radiation therapy
Exception: within 3 weeks prior to the use of the investigational drug
Subjects who have received systemic anti-tumor therapy or radiation therapy within 3 weeks prior to the use of the investigational drug
Cannot have received: IDH2 inhibitor
Subjects who have previously used targeted isocitrate dehydrogenase 2 (IDH2) inhibitors
Lab requirements
Blood counts
Blood platelet (PLT) ≥20×10^9/L; or PLT<20 × 10^9/L, but recognized by the researchers as being caused by tumor reasons
Kidney function
serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 50ml/min
Liver function
Serum total bilirubin ≤ 1.5 × ULN (for Gilbert syndrome subjects, bilirubin ≤ 3 × ULN)
Blood platelet (PLT) ≥20×10^9/L； Or subjects with PLT<20 × 10^9/L, but recognized by the researchers as being caused by tumor reasons; Serum total bilirubin ≤ 1.5 × ULN (for Gilbert syndrome subjects, bilirubin ≤ 3 × ULN); Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 50ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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