Clinical trial · Interventional
A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant Cancer
A Phase I Study to Evaluate the Safety, Tolerance and Pharmacokinetics of TQB3006 Tablets in Patients With Advanced Malignant Cancer
NCT06344351CI-TRIAL-00090057completedPhase 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 study includes two stage: dose escalation and dose extension, with a single dose and a multiple dose study. This is a single-center, open, non-randomized, single arm, study to evaluate the safety, tolerability and pharmacokinetics of TQB3006 tables in patients with advanced malignant cancer.
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 Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB3006 tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB3006 tablets
- description
- TQB3006 tables is administered as a single dose or multiple dose .Take200-1200 mg per day; Take TQB3006 orally on an empty stomach once or twice a day, 21 days as a cycle.
- interventionNames
- Drug: TQB3006 tablets
Primary outcomes (3)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- At the end of Cycle 1 (21 Days).
- description
- DLT will be defined as toxicities that meet pre-defined severity criteria (according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version5.0), and assessed as having a suspected relationship to study drug that occurred from first medication to the end of the first treatment cycle.
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- At the end of Cycle 1 (21 Days).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study; * Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1; * Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures during the study period to at least 6 months after the last dose of study drug. Exclusion Criteria: * There were other malignant tumors within 3 years; * Has multiple factors affecting oral medication; * Unalleviated toxicity ≥ grade 1 of CTCAE v5.0 due to any previous therapy , excluding hair loss; * Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study，or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period; * Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; * Have a history of psychotropic drug abuse and can not quit or have mental disorders; * Subjects with any severe and / or uncontrolled disease including active hepatitis, a history of immunodeficiency, etc.; * Tumor-related symptoms and treatment: 1. Has known symptomatic central nervous system metastases and/or cancerous meningitis; 2. Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within 1 month after receiving the investigational drug for the first time; 3. Has participated in other clinical trials within 4 weeks before first dose. * 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.