Clinical trial · Interventional
A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor
A Open-label, Single-arm Phase Ⅱ Clinical Trial of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor
NCT04412564CI-TRIAL-00046677unknownPhase 2ClinicalTrials.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)
The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with advanced malignant 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 Malignant Tumor | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQ-B3101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQ-B3101 capsules
- description
- TQ-B3101 capsules 300mg bid administered orally in 28-day cycle.
- interventionNames
- Drug: TQ-B3101
Primary outcomes (2)
- measure
- Overall response rate (ORR)
- timeFrame
- up to 48 weeks
- description
- Percentage of subjects achieving complete response (CR) and partial response (PR).
- measure
- Adverse events (AE) and serious adverse events (SAE)
- timeFrame
- up to 48 weeks
- description
- The occurrence of all adverse events (AE) and serious adverse events (SAE).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 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\. Understood and signed an informed consent form. 3. Histologically or cytologically confirmed advanced malignant solid tumors. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception. Exclusion Criteria: * 1\. Has multiple factors affecting oral medication. 2. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1. 3. Other malignancies occurred within 3 years, with exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors. 4\. Has a history of hypertension, hypertensive encephalopathy or uncontrolled hypertension. 5\. Has cardiovascular and cerebrovascular diseases. 6. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before the first dose. 7\. Has central nervous system metastasis and / or spinal cord compression, cancerous meningitis, and meningeal disease. 8\. Active hepatitis, HIV positive, syphilis positive. 9. Has a history of psychotropic substance abuse. 10. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.