Clinical trial · Interventional
A New Drug Used for Advanced Cancer
Phase I Study of Tolerance and Pharmacokinetics of TQ-B3203
NCT03447145CI-TRIAL-00031826unknownPhase 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)
To identify the safety and tolerance of TQ-B3203.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQ-B3203 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQ-B3203
- interventionNames
- Drug: TQ-B3203
Primary outcomes (7)
- measure
- The maximum tolerated dose(MTD)
- timeFrame
- 21 days
- measure
- dose-limiting toxicity(DLT)
- timeFrame
- 21 days
- measure
- Peak Plasma Concentration(Cmax)
- timeFrame
- 21 days
- measure
- Peak time(Tmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients definitedly diagnosed by pathology and/or cytology as advanced solid tumor,those who lack of standard treatments or treatment failure; * Patients treated with chemotherapy agents or surgery before being enrolled into the study need waiting for 30 days, 6 weeks will be needed if agents were Nitrocarbamide and Mitomycin C * 18-70 years old,Eastern Cooperative Oncology Group(ECOG):0-1,Life expectancy of more than 3 months,BMI:18.5-26; * Main organs function is normal; * Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device,contraceptive and condom) throughout treatment and for at least 6 months after study is stopped;the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment,and the patients required to be non-lactating;Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped; * Patients should be voluntary and sign the informed consents before taking part in the study; Exclusion Criteria: * Patients with Malignant tumors within 5 years, except for non-melanoma skin cancer and in situ cancer; * Patients who participated in other anticancer drug clinical trials within 4 weeks; * Patients treated with Irinotecan,Topotecan and any other topoisomerase I inhibitors or related clinical trials; * Patients of double locus mutation of UGT1A1\*6、UGT1A1\*28; * Patients who cannot stop using inhibitors of CYP3A4 and UGT1A1 7 days before enrolled in the study,inducers of CYP3A4 need 2 weeks. * Patients who can not be injected and patients with interstitial pneumonia or radiation pneumonia; * Patients with pericardial effusion,pleural effusion or ascitic fluid, patients with 2nd respiratory syndrome or above are refused according to National Cancer Institute Common Terminology Criteria for Adverse Events(CTC AE); * Patients with brain metastasis, spinal cord compression, cancerous meningitis, CT or MRI examination reminds patients with cerebral or soft meningeal diseases in the screening phase; * Patients with drug abuse history or unable to get rid of drugs or Patients with mental disorders; * Patients with non-healing wounds or fractures; * Patients got radiotherapy for bone metastases 2 weeks before being enrolled in the study; * Patients with urine pro 2+ and the quantitative result\>1.0g * Patients got Arteriovenous thrombosis 6 months before being the study "Blood pressure unable to be controlled ideally by one drug(systolic pressure≥150 mmHg,diastolic pressure≥90 mmHg); * Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias or cardiac insufficiency (including QTc≥480ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification);" * Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history; * Patients with thyroid dysfunction; * Patients diagnosed with glaucoma,or prostatomegaly need to be treated; * Coagulation function abnormality: haemorrhagic tendencies (e.g. active digestive tract ulcer), or are receiving thrombolytic or anticoagulant therapy * Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators; * Patient with hepatitis b surface antigen positive(HBV DNA\>1000) or hepatitis C virus(HCV);
References
Publications (0)
Data not yet available
No reference posted for this study.