Actively Recruiting
Phase I Clinical Trial to Evaluate Tolerability and Pharmacokinetics of TQB3455 Tablets in Patients With Hematological Malignancies
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2024-08-13
100
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the tolerability and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies, specifically acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). TQB3455 is an inhibitor targeting the IDH2 enzyme. The study has two stages: the first focuses on safety and tolerability of single or multiple doses in subjects with malignant blood tumors, while the second investigates the efficacy and safety of TQB3455 alone or combined with azacitidine in AML or MDS patients. During stage one, participants take TQB3455 tablets orally once daily for 28 consecutive days per treatment cycle. In stage two, participants receive the same TQB3455 tablet regimen, and some also receive azacitidine injections subcutaneously on days one through seven of each 4-week cycle. Azacitidine is a drug that affects DNA methylation. The study assesses both single and combination treatments through these cycles. Participants will be monitored with multiple assessments including dose-limiting toxicity and maximum tolerated dose during the first 28 days up to 48 weeks. Researchers will also measure overall remission rates, survival, response duration, and complete remission rates up to 48 weeks, along with detailed pharmacokinetic measurements of TQB3455 over multiple time points. Safety and tolerability are closely followed, and patients will be observed up to 96 weeks for overall survival outcomes.
CONDITIONS
Brief Title
A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with AML or MDS according to WHO classification with specific criteria for treatment difficulty or risk
- MDS patients must be in medium, high, or extremely high-risk categories by IPSS-R
- Confirmed presence of IDH2 gene mutation
- Platelet count ≥ 20 × 10^9/L or lower if due to tumor
- Serum total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN for Gilbert syndrome)
- Renal function with serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 ml/min
- Recovery from previous anti-tumor treatments to Grade I or less toxicity
- Agreement to use contraception during study and 6 months after
- Voluntary informed consent to participate
You will not qualify if you...
- Relapse after bone marrow transplantation
- Received systemic anti-tumor or radiation therapy within 3 weeks before study drug use
- Participation in other drug trials within 4 weeks before study drug use
- Conditions affecting oral medication intake like inability to swallow or intestinal issues
- Previous use of targeted IDH2 inhibitors
- Uncontrolled systemic infections (fungal, bacterial, viral)
- Poorly controlled high blood pressure despite treatment
- Serious cardiovascular diseases or factors increasing risk of prolonged QT interval
- Severe life-threatening leukemia complications
- Known central nervous system leukemia or symptoms
- History of psychotropic drug abuse or mental disorders
- Active hepatitis B or C virus replication
- Immunodeficiency conditions including HIV or history of organ transplantation
- Other serious diseases affecting safety or study completion as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles up to 48 weeks
Participants take TQB3455 tablets orally once daily for 28 consecutive days as a treatment cycle. They also receive subcutaneous injections of Azacitidine on the first to seventh day of each 4-week cycle.
Weekly visits during each 28-day cycle
Duration - Up to 96 weeks
Participants are monitored for overall survival and response duration after treatment completion.
Visits scheduled as per protocol during follow-up period
Trial Site Locations
Total: 7 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Peking University international Hospital
Beijing, Beijing Municipality, China, 102206
Not Yet Recruiting
3
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
4
Harbin The First Hospital
Harbin, Heilongjiang, China, 150010
Not Yet Recruiting
5
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 201306
Not Yet Recruiting
6
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
7
People's Hospital of Tianjin
Tianjin, Tianjin Municipality, China, 300121
Not Yet Recruiting
Research Team
H
Hao Jiang, Master
W
Wenbing Duan, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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