A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old;
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)
Extremely high-risk (>6 points)
Disqualifiers
Subjects who experience relapse after bone marrow transplantation;
Subjects who have received systemic anti-tumor therapy or radiation therapy within 3 weeks prior to the use of the investigational drug;
Individuals who have participated in clinical trials of other drugs within the four weeks prior to using the investigational drug;
Individuals with multiple factors that affect oral medication, such as inability to swallow, post gastrointestinal resection, chronic diarrhea, and intestinal obstruction;
Trial design
Design model
Single group
Treatments tested in this trial
TQB3455 tablet+Azacitidine for Injection
DrugTQB3455 is a selective IDH2 mutant enzyme inhibitor. Azacitidine for injection is a cytosine nucleoside drug that is used for demethylation therapy.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: TQB3455 tablet and Azacitidine for InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicity (DLT)
Subjects appear the toxic reaction relate to the drug after treatment within 28 days.
Time frame
Baseline up to 28 days2
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.
Time frame
Up to 48 weeks3
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.
Time frame
Up to 48 weeksSecondary outcomes
1
Overall survival (OS)
Overall survival defined as the time from enrollment to death from any cause.
Time frame
U to 96 weeks2
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.
Time frame
Up to 48 weeks3
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).
Time frame
Up to 48 weeks4
Cmax
Cmax is the maximum plasma concentration of TQB3455 or metabolite(s).
Time frame
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 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov