Clinical trial NCT03099330: A Phase I Study of TQ-B3139 on Tolerance and Pharmacokinetics
Official title: Phase I Study of Tolerance and Pharmacokinetics of TQ-B3139 in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study of TQ-B3139, inhibitor of ALK/C-Met tyrosine kinase, in patient with advanced cancer

Detailed description: phase I of safety, pharmacokinetic and pharmacodynamic study of TQ-B3139. To recommend a reasonable dose and indication for subsequent research.

Eligibility criteria: Inclusion Criteria:

* Histological documentation of Advanced solid tumors
* Lack of the standard treatment or treatment failure
* 18-65years,ECOG PS:0-1,Life expectancy of more than 3 months
* Patients with anti-treatment or surgery within 4 weeks
* 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 participated in other anticancer drug clinical trials within 4 weeks
* 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

Primary outcomes:
measure: The maximum tolerated dose (MTD) of TQ-B3139
timeFrame: 48 weeks
measure: The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3139
timeFrame: For 4 weeks for DLTs
measure: Pharmacokinetics of TQ-B3139 (in whole blood):Peak Plasma Concentration(Cmax)
timeFrame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of TQ-B3139 (in whole blood):Peak time（Tmax）
timeFrame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of TQ-B3139 (in whole blood):Half life（t1/2）
timeFrame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of TQ-B3139 (in whole blood):Area under the plasma concentration versus time curve (AUC)
timeFrame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of TQ-B3139 (in whole blood):Clearance（CL）
timeFrame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: each 28 days up to intolerance the toxicity or PD (up to 24 months)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun-Yat-Sen University Cancer Center
state: Guangdong
Study officials:
References:
citation: Ma Y, Zhao H, Xue J, Liu L, Yang N, Zhang Y, Yang H, Hong S, Xiong Y, Zhang Z, Zeng L, Pan H, Zhou C, Zhang Y, Wang X, Han X, Wan X, Shao Y, Liu J, Yang Y, Huang Y, Zhao Y, Fang W, Li S, Zhang L. First-in-human phase I study of TQ-B3139 (CT-711) in advanced non-small cell lung cancer patients with ALK and ROS1 rearrangements. Eur J Cancer. 2022 Sep;173:238-249. doi: 10.1016/j.ejca.2022.06.037. Epub 2022 Aug 5.