A Phase I Study of TQ-B3139 on Tolerance and Pharmacokinetics

NCT03099330 | Unknown Phase 1

• 1 other identifier: TQ-B3139-I-0001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (7)

• The maximum tolerated dose (MTD) of TQ-B3139

  The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment

  48 weeks

• The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3139

  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

  For 4 weeks for DLTs

• Pharmacokinetics of TQ-B3139 (in whole blood):Peak Plasma Concentration(Cmax)

  Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.

  up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

• Pharmacokinetics of TQ-B3139 (in whole blood):Peak time（Tmax）

  Peak time（Tmax）,Tmax in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.

  up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

• Pharmacokinetics of TQ-B3139 (in whole blood):Half life（t1/2）

  Half life（t1/2）,t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.

  up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

• Pharmacokinetics of TQ-B3139 (in whole blood):Area under the plasma concentration versus time curve (AUC)

  Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.

  up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

• Pharmacokinetics of TQ-B3139 (in whole blood):Clearance（CL）

  Clearance（CL）,CL in L/h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.

  up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

Secondary Outcomes (1)

• Objective Response Rate (ORR)

  each 28 days up to intolerance the toxicity or PD (up to 24 months)

Study Arms (1)

TQ-B3139

EXPERIMENTAL

TQ-B3139 p.o. qd

Drug: TQ-B3139

Interventions

TQ-B3139 DRUG

TQ-B3139 p.o. qd

TQ-B3139

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological documentation of Advanced solid tumors
• Lack of the standard treatment or treatment failure
• years,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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Sun-Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35940055 DERIVED

Central Study Contacts

Li Zhang, doctor

CONTACT

020-87343088; Zhangli6@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: July 19, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 18, 2017

Record last verified: 2017-03

Locations

CN (1)