Status:
UNKNOWN
A Study of TQB3473 Tablets in Subjects With Relapsed or Refractory Hematological Malignancies
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Relapsed/Refractory Hematological Malignancies
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 tablet...
Eligibility Criteria
Inclusion
- 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.
- 4\. Has at least one measurable lesion. 5. Adequate organ system function. 6. Patients need to adopt effective methods of contraception.
Exclusion
- 1\. 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.
- 3\. 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.
- 8\. 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.
- 10\. 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.
Key Trial Info
Start Date :
October 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04412577
Start Date
October 12 2020
End Date
June 1 2022
Last Update
April 1 2021
Active Locations (2)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
2
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032