A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics

NCT03850873 | Completed Phase 1

• 1 other identifier: TQB3616-I-0001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

TQB3616 may work in cancer by stopping cancer cells from multiplying.TQB3616 is in a new class of drugs called CDK inhibitors.This research study is the first time that TQB3616 will be given to people.TQB3616 is taken by mouth daily.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (2)

• DLT

  Dose-Limiting Toxicities

  Baseline up to 28 days

• MTD

  Maximum Tolerated Dose

  Baseline up to 28 days

Secondary Outcomes (4)

• Cmax

  Hour 0(pre-dose),1,2,4,6,8,12,24,36,48,72,120,168hours post-dose on single dose ; Hour 0(pre-dose) of day1,day7,day14,day21,day28 on multiple dose and Hour 0(pre-dose),1,2,4,6,8,12,24hours post-dose on multiple dose of day28

• Tmax

  Hour 0(pre-dose),1,2,4,6,8,12,24,36,48,72,120,168hours post-dose on single dose ; Hour 0(pre-dose) of day1,day7,day14,day21,day28 on multiple dose and Hour 0(pre-dose),1,2,4,6,8,12,24hours post-dose on multiple dose of day28

• t1/2

  Hour 0(pre-dose),1,2,4,6,8,12,24,36,48,72,120,168hours post-dose on single dose ; Hour 0(pre-dose) of day1,day7,day14,day21,day28 on multiple dose and Hour 0(pre-dose),1,2,4,6,8,12,24hours post-dose on multiple dose of day28

• AUC

  Hour 0(pre-dose),1,2,4,6,8,12,24,36,48,72,120,168hours post-dose on single dose ; Hour 0(pre-dose) of day1,day7,day14,day21,day28 on multiple dose and Hour 0(pre-dose),1,2,4,6,8,12,24hours post-dose on multiple dose of day28

Study Arms (1)

TQB3616

EXPERIMENTAL

TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m to 120mg once daily

Drug: TQB3616

Interventions

TQB3616 DRUG

TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m，40mg，60mg，80mg，100mg，120mg once daily

TQB3616

Eligibility Criteria

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

You may qualify if:

• ≥18 years old
• Patients definitely diagnosed by pathology and/or cytology as advanced breast cancer with ER+、Her2-,who failed with standard endocrine therapy.
• ECOG PS:0-1,Survival is expected to be greater than 3 months
• Main organs function is normal or must meet the following criteria(within past 14 days) 1) hemoglobin≥90g/L; neutrophils≥1.5 x109/L; Platelets≥100 x109/L 2)Albumin≥29g/L; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase(AST) and alanine transaminase(ALT)≤2.5 ULN, and ≤ 5 x ULN with hepatic metastasis;serum creatinine ≤1.5 xULN，creatinine clearance \>60ml/min; Triglyceride≤3.0mmol/L, cholesterol≤7.75mmol/L
• )Doppler ultrasound evaluation: Left ventricular ejection fraction(LVEF)≥50% 5.Patients should be voluntary and sign the informed consent before taking part in the study

You may not qualify if:

• Patients with malignant tumors, except for Cured cutaneous basal cell carcinoma and cervical carcinoma in situ
• Prior treatment with chemotherapy with cytotoxic drugs within 4 weeks, mitomycin C or nirtosocarbamide within 8 weeks
• Prior treatment with any anti-cancer therapy including hormone therapy radioimmunotherapy, molecular targeted therapy, immunotherapy or other biological therapy with 2 weeks
• Patients treated with other CDK4/6 inhibitors;
• 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;
• Previous history of stem cell or bowe marrow transplant;
• A variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, intestinal obstruction, etc.)
• Patients with non-healing wounds or fractures, except for bone metastatics with pathologic frature
• Previous history of uncontrolled cardiovascular disease including: a) Grade 3 or higher congestive heart failure (NYHA Classification);b)unstable angina pectoris or newly developped angina pectoris within 3months before the trial; c) Myocardial in farction or stroke occured within 6 months prior to intiation of trial; d) Arrhythmias requiring antiarrhythmic treatment(beta-blocker or digoxin is permitted)
• Patients who need to take CYP3A4 inhibitors or inducers from the screening period;
• Patients with drug abuse history or unable to get rid of drugs or Patients with mental disorders
• Patients with the urine protein≥2+, total ammount of 24 hours urinary protein determination\>1.0 grams;
• Patients with hyperactive/venous thrombosis events within 6 months,such as cerebrovascular accidents (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism
• Patients with active hepatitis b or c infection
• Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;

Sponsors & Collaborators

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

Study Sites (4)

Fifth Medical Center of Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100039, China

Location

The Fourth Hospital of Hebei Medical University and Hebei

Shijiazhuang, Hebei, 050011, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 45008, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 212028, China

Location

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: February 20, 2019
• First Posted: February 22, 2019
• Study Start: May 20, 2019
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (4)