Clinical trial · Interventional
A Phase I Study of TQ-B3101 on Tolerance and Pharmacokinetics
Phase I Study of Tolerance and Pharmacokinetics of TQ-B3101 in Patients With Advanced Cancer
NCT03019276CI-TRIAL-00029578unknownPhase 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 study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a reasonable regimen for subsequent research.
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 Cancer | 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
- description
- TQ-B3101 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- interventionNames
- Drug: TQ-B3101
Primary outcomes (7)
- measure
- The maximum tolerated dose (MTD) of TQ-B3101
- timeFrame
- 48 weeks
- description
- The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment
- measure
- The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3101
- timeFrame
- For 4 weeks for DLTs
- description
- Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histological documentation of Advanced solid tumors * Lack of the standard treatment or treatment failure * 18-70years,ECOG PS:0-1,Life expectancy of more than 3 months * 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 participate in the study voluntarily and sign informed consent Exclusion Criteria: * Patients with treatment failure by ALK/ROS1 inhibitor * Patients with anti-teratment,radiotherapy or surgery within 4 weeks * Patients participated in other anticancer drug clinical trials within 4 weeks or ALK/ROS1 inhibitor within 1 week * Blood pressure unable to be controlled(systolic pressure\>140 mmHg，diastolic pressure\>90 mmHg). Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥470ms) * Patients with non-healing wounds or fractures * Patients with drug abuse history and unable to get rid of or Patients with mental disorders * History of immunodeficiency * Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
References
Publications (1)
- DERIVEDLu S, Pan H, Wu L, Yao Y, He J, Wang Y, Wang X, Fang Y, Zhou Z, Wang X, Cai X, Yu Y, Ma Z, Min X, Yang Z, Cao L, Yang H, Shu Y, Zhuang W, Cang S, Fang J, Li K, Yu Z, Cui J, Zhang Y, Li M, Wen X, Zhang J, Li W, Shi J, Xu X, Zhong D, Wang T, Zhu J. Efficacy, safety and pharmacokinetics of Unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a Phase I/II Trial. Signal Transduct Target Ther. 2023 Jun 30;8(1):249. doi: 10.1038/s41392-023-01454-z. PMID 37385995