Metastatic Triple-negative Breast CancerPhase 1/2NCT05746728
Surufatinib Combined With Tislelizumab in the Second-line and Further Treatment of Triple-negative Breast Cancer
A Phase 1/2 study testing Surufatinib and Tislelizumab in people with Metastatic Triple-negative Breast Cancer, run by Huihua Xiong at 1 site in China.
Trial summary
This is a multicenter, open-label, single-arm clinical study designed to evaluate the safety and efficacy of surufatinib combined with tislelizumab in the treatment of metastatic triple-negative breast cancer (TNBC). The study will be conducted in two parts; Safety lead-in phase and dose expansion phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Triple-negative Breast Cancer
- What is being tested?
- Surufatinib and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Apr 2023to Aug 2025
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily participated in the study, signed the informed consent, and had good compliance;
- Female patients ≥18 years;
- TNBC confirmed by histology or cytology. Triple negative is defined as <1% expression of estrogen receptor (ER) and progesterone receptor (PR), and negative in situ hybridization expression of human epidermal growth factor receptor 2 (HER2).
- Unresectable locally advanced or metastatic TNBC failed or relapsed after treatment with at least one line of standard chemotherapy regimens (taxanes and/or anthracyclines). For patients with documented germ line BRCA1/BRCA2 (breast cancer 1 gene/breast cancer 2 gene) mutations, PARP inhibitors can be considered as one of the previous standard therapies if they have been treated with approved PARP inhibitors;
- Patients should have at least one measurable lesion (RECIST 1.1);
- ECOG PS 0 or 1;
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- Expected survival ≥12 weeks;
- Blood test (without blood transfusion within 14 days)
- Neutrophil absolute value ≥1.5×109/L, platelet ≥100×109/L, hemoglobin concentration ≥9g/dL);
- Liver function test (aspartate aminotransferase and glutamic aminotransferase ≤2.5×ULN, bilirubin ≤1.5×ULN; In the presence of liver metastasis, AST and ALT≤5×ULN);
- Renal function (serum creatinine ≤1.5×ULN, or creatinine clearance (CCr)≥60ml/min);
- Coagulation, International standardized ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thrombin time (APTT) ≤1.5×ULN;
- Thyroid function, thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN); If abnormal, FT3 and FT4 levels should be examined, and normal FT3 and FT4 levels can be included.
- Women of reproductive age must undergo a negative serum pregnancy test within 14 days prior to treatment and be willing to use medically approved effective birth control (e.g., intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last study drug use.
Who cannot join
- During the first 4 weeks of treatment, receive the following treatments: including but not limited to surgery, chemotherapy, radical radiotherapy, biotargeted therapy, immunotherapy, and other investigational drugs;
- Previous treatment with anti-VEGF /VEGFR targeting drugs, such as Surufatinib; Or have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or synergistic inhibition of T cell receptors in response to another stimulus (including but not limited to CTLA-4, OX-40, LAG-3, CD137, etc.);
- Immunosuppressive drugs have been administered in the 14 days prior to initiation of treatment, but do not include nasal and inhaled corticosteroid hormones or physiological doses of systemic steroid hormones (i.e., the daily dose of prednisolone does not exceed 10 mg or the equivalent physiological dose of another corticosteroid);
- History of any active autoimmune disease or autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or asthma may have complete remission in childhood and do not currently require medical intervention, or have a history of allotransplantation or allohematopoietic stem cell transplantation);
- Symptomatic brain or meningeal metastases (except those with brain metastases that have undergone local radiotherapy or surgery for more than 6 months and whose disease control is stable);
- Severe infection (e.g. intravenous antibiotic, antifungal, or antiviral) within 4 weeks of treatment, or unexplained fever > 38.5 ℃ during screening/initial administration;
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- Have high blood pressure that is not well controlled by antihypertensive medications (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
- Urine routine indicated urine protein ≥2+, and 24 hours urine protein quantity >1.0g;
- Obvious clinical bleeding symptoms or obvious bleeding tendency (bleeding > 30 mL within 3 months, hematemesis, black feces, blood in stool), hemoptysis (fresh blood > 5 mL within 4 weeks) within 3 months prior to treatment. Or treatment of venous/venous thrombosis events occurring within the preceding 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day) is required;
- Active heart disease, including myocardial infarction, severe/unstable angina, occurs 6 months before treatment. Left ventricular ejection fraction < 50% by echocardiography and poor arrhythmia control (including QTcF interval, > 450 ms in men and > 470 ms in women);
- The patient has had other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the previous 3 years or at the same time.
- Known allergy to the study drug or any of its excipients, or severe allergic reaction to other monoclonal antibodies;
- Active or uncontrolled severe infection;
- Known human immunodeficiency virus (HIV) infection;
- A known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., HBV DNA positive (>1×104 copies /mL or >2000 IU/ml) must be excluded for a known hepatitis B virus (HBV) carrier;
- Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis];
- Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, the patient has a medical condition or condition that is reasonably suspected to be unsuitable for the use of the study drug (such as the presence of epileptic seizures requiring treatment), or which would interfere with the interpretation of the study results, or place the patient at high risk;
- The patients considered by the investigators to be unsuitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Huihua Xiong, PI, 02783663405, xionghuihua@hotmail.com
About this study
Official title: A Multicenter, Open-label, Single-arm Study of Surufatinib in Combination With Tislelizumab for Second-line and Further Treatment of Metastatic Triple-negative Breast Cancer (TNBC)
This is a multicenter, open-label, single-arm clinical study designed to evaluate the safety and efficacy of surufatinib combined with tislelizumab in the treatment of metastatic triple-negative breast cancer (TNBC). The study will be conducted in two parts; Safety lead-in phase and dose expansion phase.
- Conditions
- Metastatic Triple-negative Breast Cancer
- Being tested
- Surufatinib, Tislelizumab
- Keywords
- Surufatinib plus Tislelizumab, TNBC
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
Safety run-in phase: 200-250mg, QD, Q3W
Dose expansion phase: according to the dose determined in the safety run-in phase
TislelizumabDrug
200mg, d1, iv, Q3W
| Study group | Role | What they receive |
|---|---|---|
| surufatinib + tislelizumab | Experimental | Safety Lead-in Phase: Six patients with metastatic triple-negative breast cancer will be recruited to receive surufatinib in combination with tislelizumab, and DLT will be evaluated over a 28-day DLT observation period.
Dose expansion phase: Surufatinib was administered according to the dose determined in the safety run-in phase and tislelizumab is same as Safety Lead-in Phase. Receives: Drug: Surufatinib; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
time from initial treatment to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: approximately 1 years
Secondary outcomes (3)
Objective response rate (ORR)
the proportion of patients with complete response or partial response, using RECIST v 1.1.
Measured: approximately 1 years
Disease Control Rate (DCR)
the proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.
Measured: approximately 1 years
Overall survival (OS)
time from initial treatment to death from any cause.
Measured: approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study startApr 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Triple-negative Breast CancerStudies of the same condition, open and under way.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huihua Xiong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huihua Xiong, Tongji Hospital
- Investigators
- Huihua Xiong, Principal investigator, Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746728
- Sponsor's protocol ID
- HMPL-012-SPRING-R103
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 6 Apr 2023
- 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 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm Study of Surufatinib in Combination With Tislelizumab for Second-line and Further Treatment of Metastatic Triple-negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT05746728
- Acronym / sponsor ID
- HMPL-012-SPRING-R103
- Conditions
- Metastatic Triple-negative Breast Cancer
- Keywords
- Surufatinib plus Tislelizumab, TNBC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Huihua XiongUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 28 Feb 2023 (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.
This is a multicenter, open-label, single-arm clinical study designed to evaluate the safety and efficacy of surufatinib combined with tislelizumab in the treatment of metastatic triple-negative breast cancer (TNBC). The study will be conducted in two parts; Safety lead-in phase and dose expansion phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surufatinib + tislelizumab | Experimental | Drug: Surufatinib, Drug: TislelizumabSafety Lead-in Phase: Six patients with metastatic triple-negative breast cancer will be recruited to receive surufatinib in combination with tislelizumab, and DLT will be evaluated over a 28-day DLT observation period. Dose expansion phase: Surufatinib was administered according to the dose determined in the safety run-in phase and tislelizumab is same as Safety Lead-in Phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients voluntarily participated in the study, signed the informed consent, and had good compliance;
- Female patients ≥18 years;
- TNBC confirmed by histology or cytology. Triple negative is defined as <1% expression of estrogen receptor (ER) and progesterone receptor (PR), and negative in situ hybridization expression of human epidermal growth factor receptor 2 (HER2).
- Unresectable locally advanced or metastatic TNBC failed or relapsed after treatment with at least one line of standard chemotherapy regimens (taxanes and/or anthracyclines). For patients with documented germ line BRCA1/BRCA2 (breast cancer 1 gene/breast cancer 2 gene) mutations, PARP inhibitors can be considered as one of the previous standard therapies if they have been treated with approved PARP inhibitors;
- Patients should have at least one measurable lesion (RECIST 1.1);
Key exclusion criteria (18 listed)
- During the first 4 weeks of treatment, receive the following treatments: including but not limited to surgery, chemotherapy, radical radiotherapy, biotargeted therapy, immunotherapy, and other investigational drugs;
- Previous treatment with anti-VEGF /VEGFR targeting drugs, such as Surufatinib; Or have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or synergistic inhibition of T cell receptors in response to another stimulus (including but not limited to CTLA-4, OX-40, LAG-3, CD137, etc.);
- Immunosuppressive drugs have been administered in the 14 days prior to initiation of treatment, but do not include nasal and inhaled corticosteroid hormones or physiological doses of systemic steroid hormones (i.e., the daily dose of prednisolone does not exceed 10 mg or the equivalent physiological dose of another corticosteroid);
- History of any active autoimmune disease or autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or asthma may have complete remission in childhood and do not currently require medical intervention, or have a history of allotransplantation or allohematopoietic stem cell transplantation);
- Symptomatic brain or meningeal metastases (except those with brain metastases that have undergone local radiotherapy or surgery for more than 6 months and whose disease control is stable);
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 |
|---|---|---|
| SurufatinibSafety run-in phase: 200-250mg, QD, Q3W Dose expansion phase: according to the dose determined in the safety run-in phase | Drug | surufatinib + tislelizumab |
| Tislelizumab200mg, d1, iv, Q3W | Drug | surufatinib + tislelizumab |
Primary outcome
Progression-free survival
Time frame: approximately 1 years
time from initial treatment to the first documented disease progression or death due to any cause, whichever occurs first.
3 secondary outcomes
Objective response rate (ORR)
Time frame: approximately 1 years
Disease Control Rate (DCR)
Time frame: approximately 1 years
Overall survival (OS)
Time frame: approximately 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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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.
Huihua Xiong principal investigator
Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Surufatinib and Tislelizumab in people with Metastatic Triple-negative Breast Cancer, run by Huihua Xiong at 1 site 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 14 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: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huihua Xiong, PI (027-83663405, xionghuihua@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: approximately 1 years). 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 6 Apr 2023.