A Phase I Study of TQ-B3395 on Tolerance and Pharmacokinetics

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To study the pharmacokinetic characteristics of TQ-B3395 in the human body, recommend a reasonable regimen for subsequent research.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Criteria

Inclusion Criteria:

• Histological documentation of Advanced solid tumors,lack of the standard treatment or treatment failure.In expanding stage,enroll the Non-small Cell Lung Cancer with EGFR+(except exon 20)

• 18-70 years,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:

• 14 Days or more from the last cytotoxic therapy

• Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now

• Blood pressure unable to be controlled ideally by one drug(systolic pressure≥140 mmHg，diastolic pressure≥90 mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥470ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification)

• 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