Breast CancerPhase 1/2NCT07697443
Clinical Trial of TQB3126 for Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Breast Cancer Subjects
A Phase 1/2 study testing TQB3126 in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 6 sites in China.
Trial summary
The study includes Phase I dose escalation and expansion and Phase II combination therapy. It uses a multicenter, open-label, non-randomized design to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3126 in breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TQB3126
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 6 sitesChina
- Study dates
- 12 Sep 2026to Aug 2030
- Phase
- Phase 1/2
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good treatment compliance.
- Aged 18 to 75 years at the time of informed consent signature; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; estimated survival expectancy of more than 3 months.
- Histopathologically confirmed breast cancer.
- Documented disease progression confirmed by clinical or imaging evidence during or after the most recent prior systemic therapy prior to the first study drug administration.
- Have evaluable lesions per RECIST v1.1 criteria (measurable lesions; or bone-only metastases with at least one osteolytic or mixed lesion).
- Adequate tissue samples shall be provided at screening for gene mutation testing to clarify genetic status.
- Laboratory test results meet the criteria specified in the protocol (blood routine, liver and renal function, coagulation function, cardiac ultrasound Left Ventricular Ejection Fraction(LVEF) and other indicators are all within the protocol-specified ranges).
- Subjects of childbearing potential must agree to use effective contraceptive measures throughout the study and for 6 months after study completion (the same requirement applies to male subjects); serum or urine pregnancy test result is negative within 7 days prior to enrollment.
Who cannot join
- Other malignant tumors within 5 years prior to first dose, except those cured by single surgical treatment with at least 5 years of disease-free survival, or cured differentiated thyroid cancer, cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumors.
- Conditions affecting intravenous access or blood sampling, or multiple factors affecting oral drug administration/absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction).
- Unresolved toxicity from prior therapy of Grade >1 (CTCAE v6.0), except Grade 2 alopecia, Grade 2 anemia, clinically insignificant laboratory abnormalities, or hypothyroidism stable on hormone replacement therapy.
- Major surgery, significant traumatic injury within 4 weeks before first dose, anticipated need for major surgery during the study, or long-standing unhealed fracture.
- Any bleeding event of Grade >=3 within 4 weeks before first dose.
- Arterial/venous thrombotic events within 6 months before first dose (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism), excluding catheter-related or superficial venous thrombosis.
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- Active viral hepatitis that is poorly controlled (Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)-infected subjects meeting protocol-specified criteria may be enrolled).
- Active syphilis infection requiring treatment.
- Active tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or radiation pneumonitis requiring treatment, or history of/current interstitial lung disease (ILD).
- History of psychotropic substance abuse unable to be discontinued, mental disorders, epilepsy requiring treatment, or severe psychiatric/neurological disease.
- Planned or prior allogeneic bone marrow or solid organ transplantation.
- Decompensated cirrhosis (Child-Pugh Class B or C) or history of hepatic encephalopathy.
- Significant cardiovascular disease, including New York Heart Association(NYHA) Class >II heart failure, clinically significant ventricular arrhythmia, unstable angina, myocardial infarction within 12 months, markedly prolonged QT interval corrected by Fridericia's formula (QTcF), or personal/family history of congenital long QT syndrome.
- Poorly controlled hypertension (resting systolic BP >=160 mmHg or diastolic BP >=100 mmHg on at least 2 measurements >=24 hours apart).
- Active or uncontrolled serious infection (Grade >=2).
- Renal failure requiring hemodialysis or peritoneal dialysis; or history of/current nephrotic syndrome (except cured) or chronic nephritis.
- History of immunodeficiency, including HIV infection or other acquired/congenital immunodeficiency diseases.
- Poorly controlled autoimmune disease requiring immunosuppressants or systemic corticosteroids for immunosuppression, continued within 7 days before first dose (except low-dose corticosteroids).
- Clinically significant endometrial abnormalities (including hyperplasia, dysfunctional uterine bleeding, etc.).
- Tumor-related conditions/treatments: anti-cancer therapy within 3 weeks before first dose or still within the drug's washout period; prior local radiotherapy not meeting protocol-specified interval or target lesion requirements; use of National Medical Products Administration (NMPA)-approved proprietary Chinese medicine with anti-tumor indications within 1 week before first dose; imaging showing tumor invasion of major vessels with risk of fatal hemorrhage; uncontrolled pleural effusion/ascites/moderate-or-greater pericardial effusion requiring repeated drainage; known leptomeningeal metastasis or uncontrolled brain metastasis symptoms; severe skeletal-related events due to bone metastases.
- Known hypersensitivity to the study drug or its excipients.
- Participation in and use of another investigational anti-tumor drug within 4 weeks before first dose.
- Any concomitant disease or condition that, in the investigator's judgment, seriously endangers subject safety or study compliance, or any other reason making the subject unsuitable for enrollment.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Jun Zhang, Doctor, +86 13973131500, 296864403@qq.com
Chengxian Guo, Doctor, 15580992599, gchxyy@163.com
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Hao Wang, Doctor, +86 13518204307, unique909@126.com
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510288
Herui Yao, Doctor, +86 13500018020, yaohrsysu@163.com
- Recruiting
Meizhou People's Hospital
Meizhou, Guangdong, 514000
Jingna Wu, Doctor, +86 13431819838, 547511952@qq.com
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300202
Yehui Shi, Doctor, +86 18622221183, shiyehui@tjmuch.com
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
Haijun Yu, Doctor, +86 13971665181, doctoryhj@126.com
About this study
Official title: Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3126 in Subjects With Breast Cancer
The study includes Phase I dose escalation and expansion and Phase II combination therapy. It uses a multicenter, open-label, non-randomized design to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3126 in breast cancer. Phase I dose escalation uses a Rolling 6 design after accelerated titration at the first dose, with dose decisions reviewed by the Safety Review Committee. Dose expansion includes two cohorts of approximately 20-60 participants each. The study also explores relationships between drug exposure and efficacy/safety, including concentration-QTc assessment using Holter electrocardiograms.
- Conditions
- Breast Cancer
- Being tested
- TQB3126
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3126Drug
TQB3126 is a targeted protein degrader.
| Study group | Role | What they receive |
|---|---|---|
| TQB3126 | Experimental | TQB3126 is to be administered orally in accordance with the protocol. Dose modifications and adjustments to the dosing frequency shall be made only with the unanimous consent of the SRC. Receives: Drug: TQB3126 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
DLT is defined as toxicities that meet pre-defined severity criteria (according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 6.0) and are assessed as related to TQB3126, occurring from the first dose to the end of the first treatment cycle.
Measured: From first dose of TQB3126 to the end of Cycle 1, approximately 35 days.
Maximum Tolerated Dose (MTD)
MTD is the highest dose at which DLT occurs in less than 33% of evaluable subjects during the DLT assessment window, from the first dose of TQB3126 through the end of the first repeated-dose treatment cycle.
Measured: From first dose of TQB3126 to the end of Cycle 1, approximately 35 days.
Recommended Phase II Dose (RP2D)
The dose recommended for Phase II study based on integrated safety, tolerability, pharmacokinetic and efficacy data.
Measured: Observation is expected to continue through Cycle 6 Day 28 throughout the study, around 6 months.
Adverse Events (AEs)
The occurrence, incidence and severity of all adverse events (AEs).
Measured: From the time of first dose of TQB3126 to 28 days after the last dose or until the start of other anti-tumor therapy, whichever occurs first.
Serious Adverse Events (SAEs)
The occurrence, incidence and severity of all serious adverse events (SAEs).
Measured: From the time of first dose of TQB3126 to 28 days after the last dose or until the start of other anti-tumor therapy, whichever occurs first.
Abnormal Incidence of Laboratory Test Indicators
Incidence and severity of abnormal laboratory values.
Measured: From the time of first dose of TQB3126 to 28 days after the last dose or until the start of other anti-tumor therapy, whichever occurs first.
Objective Response Rate (ORR)
The proportion of subjects with a best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1.
Measured: From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years.
Maximum Applicable Dose (MAD)
MAD is the dose at which a dose-exposure plateau is reached, further dose escalation poses substantial safety risk, or available data indicate that a safe and effective optimal target dose has been identified.
Measured: From the first dose of TQB3126 through completion of the Phase I dose-escalation assessment.
Secondary outcomes (12)
Peak Concentration (Cmax)
Maximum observed plasma concentration of TQB3126.
Measured: Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1.
Time to Reach Maximum Plasma Concentration (Tmax)
Time to reach the maximum plasma concentration of TQB3126.
Measured: Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1.
Elimination Half-life (t1/2)
Elimination half-life of TQB3126 after oral dosing.
Measured: Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1.
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t)
Area under the plasma concentration-time curve from time zero to the last measurable concentration.
Measured: Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1.
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞)
Area under the plasma concentration-time curve from time zero extrapolated to infinity.
Measured: Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1.
Apparent Clearance (CL/F)
Apparent total clearance of TQB3126 from plasma.
Measured: Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1.
Apparent Volume of Distribution (Vz/F)
Apparent volume of distribution of TQB3126 in plasma.
Measured: Escalation: pre-dose+0.5,1,2,3,4,6,8,12,24,48,72,120 hours post single dose (Cycle0); pre-dose Cycle1 Day1. Expansion/combo: pre-dose+0.5-12 hours Cycle1 Day1; 24 hours Day2. All: pre-dose Day 7,14,21; pre-dose+0.5-12 hours Day 28; pre-dose Cycle2 Day1.
Clinical Benefit Rate (CBR)
The proportion of subjects with a best overall response of complete response, partial response, or stable disease lasting a pre-specified minimum duration, per RECIST v1.1.
Measured: From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years.
Disease Control Rate (DCR)
The proportion of subjects with a best overall response of complete response, partial response, or stable disease, per RECIST v1.1.
Measured: From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years.
Duration of Response (DOR)
The time from the first documentation of complete or partial response to the first documentation of disease progression.
Measured: From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years.
Progression-Free Survival (PFS)
The time from the first dose to the first documentation of disease progression or death from any cause, whichever occurs first.
Measured: From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years.
Time to Response (TTR)
The time from the first dose to the first documentation of complete or partial response.
Measured: From the date of first dose until the date of first documented disease progression, assessed up to approximately 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start12 Sep 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
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
- NCT07697443
- Sponsor's protocol ID
- TQB3126-I/II-01
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No