Triple Negative Breast CancerPhase 1/2NCT07139470
Sacituzumab Tirumotecan Plus Anlotinib for Metastatic Triple Negative Breast Cancer
A Phase 1/2 study testing Sacituzumab Tirumotecan + anlotinib in people with Triple Negative Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is an open-label, single-arm, multicenter phase I/II study to evaluate the safety and efficacy of sac-TMT plus anlotinib in previously treated mTNBC. The study is expected to enroll up to 59 eligible patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Sacituzumab Tirumotecan + anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 15 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years at the time of signing informed consent.
- Histologically and/or cytologically confirmed triple-negative breast cancer (TNBC) based on the most recent biopsy or pathological specimen, including:
- Definition of human epidermal growth factor receptor 2 (HER2) negative: immunohistochemistry (IHC) of 0 or 1+; if HER is 2+ by IHC, negative HER2 expression must be confirmed by fluorescence in situ hybridization (FISH);
- Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC.
- Patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least one line of standard of care regimens, including:
- Any treatment received by the patients regardless of triple-negative state can be included as one of the standard of care regimens;
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- For neoadjuvant and/or adjuvant chemotherapy, if relapse or disease progression to unresectable locally advanced or metastatic disease occurs during treatment or within 12 months after discontinuation of treatment (at least 2 cycles have been completed), it will be considered as one of the standard of care regimens;
- For patients with documented germline BRCA1/BRCA2 mutations, if they have been treated with an approved PARP inhibitor, then the PARP inhibitor can be considered as one prior standard of care regimens required;
- Patients must have progressed on or were intolerable to the treatment during or after the last treatment prior to enrollment.
- Newly diagnosed brain metastases at screening must be stable for ≥4 weeks after local treatment (e.g., radiotherapy) with imaging confirmation.
- Patients must have at least one measurable lesion per RECIST v1.1 criteria; those with only skin or bone lesions cannot be included.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- With an expected survival of ≥ 12 weeks.
- Patients must have adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony stimulating factor therapy has been received within 2 weeks prior to the treatment), which is defined as follows:
- Hematology: neutrophil count (NEUT) ≥ 1.5 × 10^9/L; platelets (PLT) ≥ 100 × 10^9/L; hemoglobin ≥ 90g/L;
- Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), for patients with liver metastases, ALT and AST must be ≤ 5 × ULN; Albumin ≥ 30g/L; total bilirubin (TBIL) ≤ 1.5 × ULN;
- Renal function: creatinine clearance (Ccr) ≥ 50 ml/min;
- Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5 × ULN.
- Patients of childbearing potential (male or female) must use effective medical contraception from consent until 6 months after the end of the dosing period.
- Patients voluntarily participate in the study, sign the informed consent form, and will be able to comply with the protocol-specified visits and relevant procedures.
Who cannot join
- Previously received any of the following treatments (including in the adjuvant or neoadjuvant setting):
- TargetedTROP2therapy;
- Any drug treatment targeting topoisomeraseI, including antibody-drug conjugates (ADC) therapy;
- Anti-angiogenic drugtherapy.
- Patients with multiple factors affecting oral medication.
- Known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis, and/or compression, active central nervous system (CNS) metastasis. Patients with previously treated brain metastases can participate if clinically stable for at least 4 weeks before dosing and do not require corticosteroids or anticonvulsants for at least 14 days. Patients with untreated asymptomatic brain metastases must require investigator approval.
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- Within 3 years before administration having other malignancies (except for those cured by local treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.).
- Presence of any of the following cardiovascular diseases or risk factors:
- Within 6 months before administration, myocardial infarction, unstable angina, acute or persistent myocardial ischemia, grade 3 or grade 4 heart failure, symptomatic or poorly controlled severe arrhythmias, cerebrovascular accident, transient ischemic attack, and other severe cardiovascular diseases;
- History of myocarditis, primary cardiomyopathy, specific cardiomyopathy, and other myocardial diseases;
- Within 3 months before administration, any deep vein thrombosis (if stabilized by low molecular weight heparin or similar drugs≥ 2 weeks, enrollment is allowed), peripheral arterial thromboembolism, pulmonary embolism, or other severe thromboembolic events;
- Presence of aortic aneurysm, aortic dissection aneurysm, or other major vascular diseases that may be life-threatening or require surgery within 6 months before administration.
- Uncontrollable systemic diseases as judged by the investigator:
- Poorly controlled diabetes (fasting blood glucose≥ 10 mmol/L on two consecutive occasions);
- Poorly controlled hypertension (systolic blood pressure> 160 mmHg and/or diastolic blood pressure> 100 mmHg);
- Presence of clinically symptomatic or requiring repeated drainage of pleural effusion, pericardial effusion, or ascites (> 1 time/week).
- Presence of steroid-requiring (non-infectious) interstitial lung disease (ILD) or a history of non-infectious pneumonia, currently having ILD or non-infectious pneumonia, or suspected ILD or non-infectious pneumonia that cannot be ruled out by imaging at screening.
- Clinically significant lung damage due to pulmonary complications, including but not limited to any underlying lung disease or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs, or previous total pneumonectomy.
- Patients with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal bleeding.
- Patients with acute gastrointestinal bleeding, persistent bleeding disorders, or bleeding tendencies such as coagulopathy.
- Toxicity from previous anti-tumor treatments has not recovered to ≤ 1grade (based on NCI CTCAE v5.0 assessment) or to the level specified by the inclusion criteria (excluding toxicities such as alopecia, fatigue, etc., judged by the investigator to be of low safety risk).
- Having an active autoimmune disease requiring systemic treatment in the past two years (including but not limited to: autoimmune hepatitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc.), systemic treatment includes disease-modifying drugs, immunosuppressants, systemic corticosteroids (> 10 mg/day prednisone or equivalent). Hormone replacement therapy, such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered a systemic treatment; within2weeks before administration> 10 mg/day prednisone systemic corticosteroid treatment or other immunosuppressive drugs.
- Known active tuberculosis.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- With ≥ 2 grade peripheral neuropathy.
- Active hepatitis B or hepatitis C.
- Human Immunodeficiency Virus (HIV) test positive or history of Acquired Immunodeficiency Syndrome (AIDS); known active syphilis infection.
- Known allergy to the study drug or any of its components, known history of severe hypersensitivity to other biological products.
- Major surgery within 4 weeks prior to dosing or expected to require major surgery during the study period.
- Severe infection within 4 weeks prior to dosing, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective treatment within 2 weeks prior to dosing.
- Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that impedes delayed corneal healing.
- Non-specific immunomodulatory treatment within 2 weeks prior to dosing (including but not limited to interferon,IL-2), approved traditional Chinese medicine preparations for anti-tumor indications, etc.
- Prior to dosing 30 days after receiving a live vaccine, or planning to receive a live vaccine during the study period.
- Rapid deterioration of the condition during the screening before administration, such as significant changes in physical status.
- Pregnant or breastfeeding women.
- Suffering from local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to high medical risk and/or uncertainty in survival evaluation, such as tumor leukemic reactions, cachexia manifestations, etc.
- Any condition that the researcher believes interferes with the evaluation of the study drug or the safety of the subject or the interpretation of the study results, or any other condition that the investigator believes is not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300000
Chunfang Hao, 86-022-60670123 Ext. 3805, haochunfang@tjmuch.com
About this study
Official title: An Open-label, Single-arm, Multicenter Phase I/II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Anlotinib in Previously Treated Metastatic Triple Negative Breast Cancer (mTNBC).
This is an open-label, single-arm, multicenter phase I/II study to evaluate the safety and efficacy of sac-TMT plus anlotinib in previously treated mTNBC. The study is expected to enroll up to 59 eligible patients.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Sacituzumab Tirumotecan + anlotinib
- 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.
Sacituzumab Tirumotecan + anlotinibDrug
Phase I part: 3 prespecified doses (sac-TMT 4mg/kg Q2W +anlotinib 8mg Q3W, sac-TMT 4mg/kg Q2W +anlotinib10mg Q3W, sac-TMT 4mg/kg Q2W +anlotinib12 mg Q3W).
Phase II part: sac-TMT patients Q2W +anlotinib RP2D Q3W.
| Study group | Role | What they receive |
|---|---|---|
| sac-TMT+anlotinib | Experimental | In the Phase I part, BOIN design was used. There were 3 prespecified doses (sac-TMT 4mg/kg Q2W +anlotinib 8mg Q3W, sac-TMT 4mg/kg Q2W +anlotinib10mg Q3W, sac-TMT 4mg/kg Q2W +anlotinib12 mg Q3W). In the Phase II part, the patients will receive sac-TMT patients Q2W +anlotinib RP2D Q3W. The treatment will continue until disease progression, unacceptable toxic effects, withdrawal from the trial, or death, whichever occurred first. Receives: Drug: Sacituzumab Tirumotecan + anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The primary endpoint of Phase I. ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Radiographic assessment of tumor response will be performed based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
Measured: up to approximately 60 months
Safety and the recommended phase 2 dose (RP2D)
The primary endpoint of Phase II. BOIN design was used to evaluate the safety and the recommended phase 2 dose (RP2D) of sac-TMT plus anlotinib
Measured: Up to Day 21
Secondary outcomes (7)
Disease control response (DCR)
DCR is defined as the proportion of participants who achieve a complete response (CR) ,partial response (PR) or stable disease (SD).
Radiographic assessment of tumor response will be performed based on RECIST v1.1
Measured: up to approximately 60 months.
Duration of response (DOR)
Measured: up to approximately 60 months
Progression-free survival (PFS)
Measured: up to approximately 60 months
Overall Survival (OS)
Measured: Until death, up to approximately 60 months.
Health-related quality of life (HRQoL) evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale
Measured: up to approximately 60 months
Health-related quality of life (HRQoL) evaluated using the NCC-BC-A scale
Measured: up to approximately 60 months
Incidence and severity of adverse events (AEs)
Measured: up to approximately 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 59 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139470
- Sponsor's protocol ID
- SKB264-IIT-001
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 24 Aug 2025
- 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 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multicenter Phase I/II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Anlotinib in Previously Treated Metastatic Triple Negative Breast Cancer (mTNBC).
- ClinicalTrials.gov ID
- NCT07139470
- Acronym / sponsor ID
- SKB264-IIT-001
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 24 Aug 2025 (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 an open-label, single-arm, multicenter phase I/II study to evaluate the safety and efficacy of sac-TMT plus anlotinib in previously treated mTNBC. The study is expected to enroll up to 59 eligible patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sac-TMT+anlotinib | Experimental | Drug: Sacituzumab Tirumotecan + anlotinibIn the Phase I part, BOIN design was used. There were 3 prespecified doses (sac-TMT 4mg/kg Q2W +anlotinib 8mg Q3W, sac-TMT 4mg/kg Q2W +anlotinib10mg Q3W, sac-TMT 4mg/kg Q2W +anlotinib12 mg Q3W). In the Phase II part, the patients will receive sac-TMT patients Q2W +anlotinib RP2D Q3W. The treatment will continue until disease progression, unacceptable toxic effects, withdrawal from the trial, or death, whichever occurred first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥ 18 years at the time of signing informed consent.
- Histologically and/or cytologically confirmed triple-negative breast cancer (TNBC) based on the most recent biopsy or pathological specimen, including:
- Patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least one line of standard of care regimens, including:
- Newly diagnosed brain metastases at screening must be stable for ≥4 weeks after local treatment (e.g., radiotherapy) with imaging confirmation.
- Patients must have at least one measurable lesion per RECIST v1.1 criteria; those with only skin or bone lesions cannot be included.
Key exclusion criteria (37 listed)
- Previously received any of the following treatments (including in the adjuvant or neoadjuvant setting):
- Patients with multiple factors affecting oral medication.
- Known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis, and/or compression, active central nervous system (CNS) metastasis. Patients with previously treated brain metastases can participate if clinically stable for at least 4 weeks before dosing and do not require corticosteroids or anticonvulsants for at least 14 days. Patients with untreated asymptomatic brain metastases must require investigator approval.
- Within 3 years before administration having other malignancies (except for those cured by local treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.).
- Presence of any of the following cardiovascular diseases or risk factors:
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 |
|---|---|---|
| Sacituzumab Tirumotecan + anlotinibPhase I part: 3 prespecified doses (sac-TMT 4mg/kg Q2W +anlotinib 8mg Q3W, sac-TMT 4mg/kg Q2W +anlotinib10mg Q3W, sac-TMT 4mg/kg Q2W +anlotinib12 mg Q3W). Phase II part: sac-TMT patients Q2W +anlotinib RP2D Q3W. | Drug | sac-TMT+anlotinib |
Primary outcome
Objective response rate (ORR)
Time frame: up to approximately 60 months
The primary endpoint of Phase I. ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response. Radiographic assessment of tumor response will be performed based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
Safety and the recommended phase 2 dose (RP2D)
Time frame: Up to Day 21
The primary endpoint of Phase II. BOIN design was used to evaluate the safety and the recommended phase 2 dose (RP2D) of sac-TMT plus anlotinib
7 secondary outcomes
Disease control response (DCR)
Time frame: up to approximately 60 months.
Duration of response (DOR)
Time frame: up to approximately 60 months
Progression-free survival (PFS)
Time frame: up to approximately 60 months
Overall Survival (OS)
Time frame: Until death, up to approximately 60 months.
Health-related quality of life (HRQoL) evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale
Time frame: up to approximately 60 months
Health-related quality of life (HRQoL) evaluated using the NCC-BC-A scale
Time frame: up to approximately 60 months
Incidence and severity of adverse events (AEs)
Time frame: up to approximately 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
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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.
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 Sacituzumab Tirumotecan + anlotinib in people with Triple Negative Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 20 inclusion and 37 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: opening soon, as of the sponsor's last update on 24 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunfang Hao (86-022-60670123 Ext. 3805, haochunfang@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to approximately 60 months). 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 24 Aug 2025.