Clinical trial · Interventional
A Study of TQB3473 Tablets in Subjects With Relapsed or Refractory Hematological Malignancies
A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3473 Tablets
NCT04412577CI-TRIAL-00050978unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB3473 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB3473 tablets
- description
- TQB3473 tablets administered once daily in 28-day cycle .
- interventionNames
- Drug: TQB3473
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- up to 31 days
- description
- MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
Secondary outcomes (6)
- measure
- Tmax
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: -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. 4\. Has at least one measurable lesion. 5. Adequate organ system function. 6. Patients need to adopt effective methods of contraception. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.