A Study of TQB3473 Tablets in Subjects With Relapsed or Refractory Hematological Malignancies
- Registration Number
- NCT04412577
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3473 tablets in Chinese adult patients with Relapsed or refractory hematological malignancies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 57
-1.Understood and signed an informed consent form. 2. Relapsed or refractory malignant hematological tumors. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
- Has at least one measurable lesion. 5. Adequate organ system function. 6. Patients need to adopt effective methods of contraception.
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Severe hypersensitivity to the drug or ingredients. 2. Has received chemotherapy, radiotherapy, immunotherapy or any other anti-tumor therapy within 14 days before the first dose.
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Has received spleen tyrosine kinase (SYK) inhibitors. 4. Has to use ≥ 10 mg/day glucocorticoid prednisone. 5. Has received BTK inhibitors and PI3K inhibitors before the first dose. 6. Has received allogeneic hematopoietic stem cell transplantation. 7. Has received autologous hematopoietic stem cell transplantation within 12 weeks before the first dose.
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Has any acute or chronic gastrointestinal diseases. 9. Has primary central nervous system lymphoma, or brain metastases with clinical symptoms, spinal cord compression, cancerous meningitis.
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Intermediate-risk or high-risk myelodysplastic syndrome. 11. Pregnancy and lactation women. 12. Has any serious and/or uncontrollable disease. 13. Has active autoimmune disease and received immunosuppressive therapy. 14. Has a history of neurological or mental disorders. 15. Has uncontrollable systemic bacterial, fungal or viral active infections 16. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1. 17. Has other malignancies. 18. Has received surgery within 4 weeks before the first administration. 19. Has participated in any other clinical trials. 20. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQB3473 tablets TQB3473 TQB3473 tablets administered once daily in 28-day cycle .
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) up to 31 days MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
- Secondary Outcome Measures
Name Time Method Tmax 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31. Cmax Cmax 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31. AUC0-t 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31. Overall response rate (ORR) up to 96 weeks Percentage of subjects achieving complete response (CR) and partial response (PR).
Progression-free survival (PFS) up to 96 weeks PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Duration of Response (DOR) up to 96 weeks DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Trial Locations
- Locations (2)
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China