Clinical trial · Interventional
A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets
A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets
NCT04481607CI-TRIAL-00055842unknownPhase 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 TQB3454 tablets in subjects with advanced solid tumor or hematologic tumor.
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 Solid Tumor or Hematologic Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB3454 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB3454 tablets
- description
- TQB3454 tablets administered orally once. Then TQB3454 tablets administered orally, once daily in 28-day cycle after 7 days of first administration.
- interventionNames
- Drug: TQB3454
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Baseline up to 28 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
- Cmax
- timeFrame
- Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
\- 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
2\. Advanced solid tumors or hematological malignancy. 3. Adequate laboratory indicators. 4. No pregnant or breastfeeding women, and a negative pregnancy test. 5. Understood and Signed an informed consent form.
Exclusion Criteria:
* 1\. Has central nervous system metastasis or system leukemia. 2.Previous anti-tumor treatment:
1. Has received IDH1 mutation inhibitor.
2. Has received systemic anti-tumor therapy or radiotherapy within 14 days before the first dose.
3. Has received oral targeted drugs, less than 5 drug half-lives from first dose.
4. The related toxicity of previous anti-tumor therapy has not recovered to CTCAE ≤ grade 2, except for hair loss.
3.Complicated disease and medical history:
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1. Active hepatitis B or hepatitis C.
2. Abnormal kidney.
3. Abnormal cardiovascular and cerebrovascular.
4. Abnormal gastrointestinal.
5. Has medical history of immunodeficiency.
6. Has bleeding (hemoptysis), coagulopathy, or been using warfarin, aspirin, and other antiplatelet agglutination drugs.
7. Has uncontrollable systemic bacterial, fungal or viral active infections.
8. Has medical history of idiopathic pulmonary fibrosis,or tissue pneumonia.
9. Has allergic constitution or previous severe allergy; or known allergy to ingredients of study drug.
10. Has neurological or mental disorders.
11. Has a history of drug abuse or drug addict.
12. Has received major surgery, open biopsy, or obvious traumatic injury within 4 weeks before the first dose.
13. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
4\. Has participated in other clinical trials within 30 days before participating in this trial.
5\. Female patients during pregnancy or lactation. 6. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
7\. criteria for solid tumors:
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1. Has any signs of bleeding constitution.
2. Has any CTCAE ≥ grade 3 bleeding or bleeding event,within 4 weeks before the first dose.
3. Has unhealed wounds, fractures, active ulcers of the stomach and duodenum, ulcerative colitis and other digestive tract diseases.
4. Imaging (CT or MRI) shows that the tumor has invaded the circumference of important blood vessels.
5. Has uncontrollable pleural effusion, pericardial effusion or ascites that still need repeated drainage.
criteria for blood tumor:
a) Has severe life-threatening leukemia complications.References
Publications (0)
Data not yet available
No reference posted for this study.