Clinical trial · Interventional
A Study of TQB3455 Tablets in Subjects With Advanced Malignancies
A Phase I Study of TQB3455 Tablets in Subjects With Advanced Malignancies
NCT04340427CI-TRIAL-00045768unknownPhase 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 open-label, multicenter, phase I study to evaluate tolerance and pharmacokinetics of TQB3455 tablets in subjects with advanced 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 |
|---|---|---|---|
| Advanced Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB3455 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB3455 Tablets
- description
- TQB3455 Tablet administered orally once. Then TQB3455 Tablet administered orally, once daily in 28-day cycle after 7 days of first administration.
- interventionNames
- Drug: TQB3455
Primary outcomes (1)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Baseline up to 28 days
- description
- Subjects appear the toxic reaction relate to the drug after treatment within 28 days.
Secondary outcomes (4)
- measure
- Cmax
- timeFrame
- Hour 0, 1, 2, 3, 5, 8, 10, 12, 24, 48, 72, 96, 120, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day22 on multiple dose and hour 0, 1, 2, 3, 5, 8, 10, 12, 24 hours post-dose on multiple dose of day 28.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. ≥ 18 years old； Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks. 2\. Has IDH2 gene mutation will be selected preferentially. 3. The toxicity of radiotherapy or other antitumor therapy should return to grade 1. 4\. No pregnant or lactating women, all the participants should use contraceptives. 5\. Understood and signed an informed consent form. 6. Advanced/metastatic solid tumors or refractory/recurrent acute myeloid leukemia. 7\. At least one measurable lesion for solid tumors. 8. Adequate organ system function. Exclusion Criteria: * 1.Relapsed after bone marrow transplantation. 2.Has received systemic antitumor therapy or radiation therapy within 3 weeks before the first dose. 3.Has participated in other clinical trial within four weeks before the first dose. 4.Has multiple factors affecting oral medication. 5.Has uncontrolled, active systemic fungal, bacterial, or viral infections. 6.Poorly controlled hypertension. 7.Has serious cardiovascular disease. 8.Has drug abuse history that unable to abstain from or mental disorders. 9.Has active hepatitis B or C. 10.Have a history of immunodeficiency. 11.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study. 12.Has central nervous system metastasis with the exception of glioma subjects. 13.Has severe life-threatening complication of leukemia, such as uncontrolled bleeding, hypoxia or shock pneumonia, and disseminated intravascular coagulation. 14.Has central nervous system leukemia.
References
Publications (0)
Data not yet available
No reference posted for this study.