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
Qualifiers
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
Treatments tested in this trial
- TQB3455 tablet+Azacitidine for Injection
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov