Phase I Clinical Trial Protocol for Tolerability and Pharmacokinetics of TQB3455 Tablets in Patients With Hematological Malignancies
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).
∙ Patients meeting all of the following inclusion criteria can be included in this trial:
• Age ≥ 18 years old;
• According to the World Health Organization (WHO) classification, subjects diagnosed with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) should meet one of the following criteria:
‣ Difficult to treat or recurrent (\>5% of primitive cells reappear in the bone marrow after complete remission) AML; (Single drug group)
⁃ Newly diagnosed AML subjects recognized by researchers as unable to receive standard treatment due to age, physical condition, or risk factors; (Joint group)
• MDS subjects belong to the following prognostic risk categories according to the revised International Prognostic Scoring System (IPSS-R):
‣ Extremely high-risk (\>6 points)
⁃ High risk (\>4.5 points - ≤ 6 points)
⁃ Medium risk (\>3 points - ≤ 4.5 points)
• Clearly indicating the presence of IDH2 gene mutation;
• 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;
• Recovery of toxic reactions caused by surgery, radiation therapy, or other anti-tumor treatments to ≤ Grade I;
• Women should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Male participants must agree to use contraception during the study period and within 6 months after the end of the study period;
• The subjects voluntarily joined this study.