A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies
NCT Number: NCT06550713
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Acute Myeloid Leukemia (AML)|Myelodysplastic Syndrome (MDS)
Interventions: DRUG: TQB3455 tablet+Azacitidine for Injection
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-10-22
Completion Date: 2026-12
Locations: Peking University People's Hospital, Beijing, Beijing, 100044, China|Peking University international Hospital, Beijing, Beijing, 102206, China|The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050000, China|Harbin The First Hospital, Harbin, Heilongjiang, 150010, China|Shanghai Sixth People's Hospital, Shanghai, Shanghai, 201306, China|West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, China|People's Hospital of Tianjin, Tianjin, Tianjin, 300121, China

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).

Primary Outcome Measures: Dose-limiting toxicity (DLT), Subjects appear the toxic reaction relate to the drug after treatment within 28 days., Baseline up to 28 days|The maximum tolerated dose (MTD), The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment., Up to 48 weeks|Overall Remission Rate, The number of participants with CR + incomplete recovery (CRi) + incomplete platelet recovery (CRp) according to modified International Working Group Acute Myeloid Leukemia (IWG AML) response criteria., Up to 48 weeks
Secondary Outcome Measures: Overall survival (OS), Overall survival defined as the time from enrollment to death from any cause., U to 96 weeks|Duration of Response (DOR), DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes., Up to 48 weeks|Complete Remission Rate, The number of participants with morphologic complete remission (CR) according to modified International Working Group Acute Myeloid Leukemia Response Criteria (IWG AML)., Up to 48 weeks|Cmax, Cmax is the maximum plasma concentration of TQB3455 or metabolite(s)., Hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12, 24, 48, 96, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day 22 on multiple dose and hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 24 hours post-dose on multiple dose of day 28|Tmax, To characterize the pharmacokinetics of TQB3455 by assessment of time to reach maximum plasma concentration., Hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12, 24, 48, 96, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day 22 on multiple dose and hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 24 hours post-dose on multiple dose of day 28|Area Under the Curve (AUC) 0-t, To characterize the pharmacokinetics of TQB3455 by assessment of area under the plasma concentration time curve from zero to infinity., Hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12, 24, 48, 96, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day 22 on multiple dose and hour 0,0.25, 0.5, 1, 2, 3, 5, 8, 12, 24 hours post-dose on multiple dose of day 28|α-Hydroxyglutaric acid (2-HG), The concentration of 2-HG., Day 1, Day 8 and Day 15 pre-dose on cycle 1; Day1, Day15 pre-dose on cycle 2 ; Day 1 pre-dose on multiple dose from cycle 3 to cycle 8. Each cycle is 28 days.