Advanced Breast CancerPhase 1NCT03850873
A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics
A Phase 1 study testing TQB3616 in people with Advanced Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- TQB3616
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesChina
- Study dates
- 20 May 2019to 23 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
- 3)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
Who cannot join
- 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;
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- 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;
- Patients allergic to TQB3616 or any adjuvant in the capsule
- Patients who took part in other trials within 4 weeks;
- Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators;
Trial locations and contacts
4 sites in 1 country.
China4 sites
Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100039
Jiangsu Province Hospital
Nanjing, Jiangsu, 212028
The Fourth Hospital of Hebei Medical University and Hebei
Shijiazhuang, Hebei, 050011
Henan Cancer Hospital
Zhengzhou, Henan, 45008
About this study
Official title: A Phase I Clinical， Tolerance and Pharmacokinetic Evaluation of 1 Schedules of Oral TQB3616，A Cyclin-Dependent Kinase Inhibitor ，In Patients With Advanced Breast Cancer
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
- Being tested
- TQB3616
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3616Drug
TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m，40mg，60mg，80mg，100mg，120mg once daily
| Study group | Role | What they receive |
|---|---|---|
| TQB3616 | Experimental | TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m to 120mg once daily Receives: Drug: TQB3616 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose-Limiting Toxicities
Measured: Baseline up to 28 days
MTD
Maximum Tolerated Dose
Measured: Baseline up to 28 days
Secondary outcomes (4)
Cmax
Maximum Observed Plasma Concentration
Measured: 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
Maximum Observed Plasma Concentration
Measured: 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
Terminal Half-life
Measured: 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
Area Under the Curve
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start20 May 2019
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850873
- Sponsor's protocol ID
- TQB3616-I-0001
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2019
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical， Tolerance and Pharmacokinetic Evaluation of 1 Schedules of Oral TQB3616，A Cyclin-Dependent Kinase Inhibitor ，In Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT03850873
- Acronym / sponsor ID
- TQB3616-I-0001
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2019 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3616 | Experimental | Drug: TQB3616TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m to 120mg once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
- 3)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
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB3616TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m，40mg，60mg，80mg，100mg，120mg once daily | Drug | TQB3616 |
Primary outcome
DLT
Time frame: Baseline up to 28 days
Dose-Limiting Toxicities
MTD
Time frame: Baseline up to 28 days
Maximum Tolerated Dose
4 secondary outcomes
Cmax
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB3616 in people with Advanced Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Baseline up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.