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TNBC - Triple-Negative Breast CancerPhase 2NCT07244874

Sac-TMT Combined With Toripalimab for First-line Treatment of PD-L1 Positive a/mTNBC

A Phase 2 study testing Sacituzumab tirumotecan and Toripalimab in people with TNBC - Triple-Negative Breast Cancer and PD-L1 Positive, run by Tianjin Medical University Cancer Institute and Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study is aimed to evaluate the efficacy and safety of Sacituzumab Tirumotecan combined with Toripalimab for first-line treatment of PD-L1 positive unresectable Locally Advanced/metastatic triple negative breast cancer (a/mTNBC). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Sacituzumab tirumotecan and Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
No sites listed yet
Study dates
1 Dec 2025to 30 Jul 2029
Phase
Phase 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients with breast cancer aged >= 18 years.
  • Based on the pathological report of the latest biopsy or other pathological specimens, the histology and/or cytology are confirmed as invasive breast cancer, and the following conditions are met: a) Pathological classification: ER <= 10%, PR <= 10%; HER2 negative (IHC 0, 1+, 2+and FISH negative); Note: Subjects with initial histopathological diagnosis of HR>10% or HER2+breast cancer and recent pathological findings of metastatic lesions meeting the above conditions are allowed to be included in the study. b) Tumor staging: locally advanced, recurrent, or metastatic tumors that cannot be surgically removed; Note: Patients who have received perioperative treatment in the past are required to have a disease-free survival period of >= 6 months;
  • ECOG overall state is 0-1.
  • Have not received systematic treatment for advanced diseases.
  • There are tissue samples available for PD-L1 testing, and the test results show PD-L1 positive: CPS >= 1.
  • The expected survival period is not less than 3 months.
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  • According to the RECIST v1.1 standard, there must be at least one measurable lesion present.
  • Having sufficient organ and bone marrow function (without receiving blood transfusion, recombinant human thrombopoietin or colony-stimulating factor therapy within 2 weeks prior to the first administration), defined as follows: a) Blood routine: neutrophil count (NEUT #) >= 1.5 × 10^9/L; platelet count (PLT) >= 100 × 10^9/L; hemoglobin >= 90g/dL; b) Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) <= 2.5 x upper limit of normal (ULN); Total bilirubin (TBIL) <= 1.5 × ULN; For patients with liver metastases, ALT and AST should be <= 5 × ULN, and TBIL should be <= 2 × ULN; For patients with liver or bone metastases, ALP <= 5 × ULN; c) Renal function: creatinine clearance rate (Ccr) >= 60ml/min; d) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <= 1.5 × ULN; e) Cardiac function: Echocardiography (ECHO) or multi circuit controlled acquisition (MUGA) scan shows left ventricular ejection fraction (LVEF) >= 50%;
  • Patients must recover from all toxicity caused by previous treatment (to <= grade 1, evaluated based on CTCAE 5.0, or meet the inclusion criteria of the protocol), except for hair loss and vitiligo.
  • Patients with negative serum pregnancy test results and those with fertility potential must agree to use effective non hormonal contraceptive methods during treatment and for at least 6 months after the last use of the test drug.
  • Voluntarily joining this study, signing informed consent, having good compliance, and willing to cooperate with follow-up.

Who cannot join

  • Patients with central nervous system metastases.
  • Received radiotherapy, endocrine therapy, chemotherapy, surgical treatment (excluding local puncture or biopsy) or molecular targeted therapy during the recurrence/metastasis stage.
  • Participated in clinical trials of other drugs within 4 weeks prior to enrollment.
  • Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L-2, or anti-CTLA-4 antibodies, or any other antibodies or drugs that specifically target T cell co stimulatory or checkpoint pathways.
  • Previously used treatment targeting TROP2 and/or topoisomerase I inhibitors.
  • Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cutaneous carcinoma, or squamous cell carcinoma of the skin.
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  • Known history of allergies to the drugs and their components in this protocol.
  • Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.
  • History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Vaccination with live vaccine within 30 days prior to the first study administration.
  • History of (non infectious) interstitial lung disease (ILD) or non infectious pneumonia requiring steroid treatment, current ILD or non infectious pneumonia, or suspected ILD or non infectious pneumonia that cannot be excluded by imaging examination during screening; Clinical severe lung damage caused by concurrent lung diseases, including but not limited to any underlying lung disease (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc. within 3 months prior to administration) or any autoimmune, connective tissue, or inflammatory disease that may affect the lungs (i.e. rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or previous total pneumonectomy.
  • Patients with active autoimmune diseases that need systematic treatment in the past two years (hormone replacement therapy is not considered as systematic treatment, such as type I diabetes, hypothyroidism requiring only thyroid hormone replacement therapy, adrenal or pituitary insufficiency requiring only physiological dose of glucocorticoid hormone replacement therapy).
  • Active infections requiring systemic treatment within 2 weeks prior to the first administration.
  • ccording to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study, including but not limited to high blood pressure beyond the control of drugs, serious diabetes, active infection, etc.
  • There is a recorded history of severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or corneal diseases that hinder delayed corneal healing.
  • Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, and female patients of childbearing age who are unwilling to take effective contraceptive measures during the trial drug treatment period and the last 6 months of medication..
  • The researchers believe that the patient is not suitable to participate in any other circumstances of this study.

About this study

Official title: A Single Arm, Phase II Study of Sacituzumab Tirumotecan（Sac-TMT） Combined With Toripalimab for First-line Treatment of PD-L1 Positive Unresectable Locally Advanced/Metastatic Triple Negative Breast Cancer (a/mTNBC)

This study is aimed to evaluate the efficacy and safety of Sacituzumab Tirumotecan combined with Toripalimab for first-line treatment of PD-L1 positive unresectable Locally Advanced/metastatic triple negative breast cancer (a/mTNBC).

Being tested
Sacituzumab tirumotecan, Toripalimab
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 tirumotecanDrug

    5mg/kg, Q2W

  • ToripalimabDrug

    240mg，Q3W

Study groups in NCT07244874
Study groupRoleWhat they receive
Sacituzumab Tirumotecan + ToripalimabExperimentalNot described
Receives: Drug: Sacituzumab tirumotecan; Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    Measured: Up to approximately 15 months

Secondary outcomes (4)

  1. Progression-Free-Survival

    Measured: Up to approximately 15 moths

  2. Duration of Response

    Measured: Up to approximately 15 months

  3. Overall Survival

    Measured: Up to approximately 4 years

  4. adverse events

    Measured: Up to approximately 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion30 Jan 2028 (estimated)
  4. Study completion30 Jul 2029 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07244874
Sponsor's protocol ID
SKB264-IIT-004
Status last verified
Jul 2025
First submitted
17 Nov 2025
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab tirumotecan and Toripalimab in people with TNBC - Triple-Negative Breast Cancer and PD-L1 Positive, run by Tianjin Medical University Cancer Institute and Hospital.

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 11 inclusion and 17 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 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

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 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?

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?

Objective response rate (ORR) (time frame: Up to approximately 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07244874.

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 Nov 2025.

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