AzTrials
AzTrials

Breast CancerPhase 2ST-A-TNNCT07371208

Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer

A Phase 2 study testing SKB264 in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a multicenter phase II trial planning to enroll 40 patients with primary triple-negative breast cancer (tumor size ≥2 cm, clinical lymph node stage cN0-3, M0). Participants will receive the combination therapy of Sac-TMT and KL-A167 during the neoadjuvant treatment phase. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Breast Cancer
What is being tested?
SKB264
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
24 Dec 2025to Aug 2030
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-65 years old.
  • Diagnosis: Histologically and/or cytologically confirmed primary triple-negative breast cancer (TNBC) (excluding inflammatory breast cancer), meeting the criteria of tumor size ≥2 cm, clinical lymph node stage cN0 to cN3, and M0 (no distant metastasis). TNBC Definition: Immunohistochemistry (IHC) showing ER and PR <10%; HER2-negative: IHC 0 or 1+, or IHC 2+ with negative in situ hybridization (ISH).
  • Tissue Sample: Availability of tumor tissue sample for biomarker testing.
  • Measurable Disease: At least one measurable lesion according to RECIST v1.1 criteria. Lesions previously irradiated cannot be selected as target lesions. Subjects with only skin lesions or bone lesions are excluded.
  • Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 within 7 days prior to treatment initiation.
  • Adequate Organ and Bone Marrow Function: Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 80 × 10⁹/L; Hemoglobin ≥ 10 g/dL. Liver Function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN. Renal Function: Creatinine clearance (Ccr) ≥ 60 mL/min (calculated using the Cockcroft-Gault formula). Coagulation: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤ 1.5 × ULN. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 55% as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan.
Show all 9Show fewer
  • Prior Treatment: No prior anti-tumor therapy for the current breast cancer.
  • Contraception: Female subjects must have a negative serum pregnancy test. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use highly effective medically approved contraceptive methods from the time of signing the informed consent form until 6 months after the last dose of study drug.
  • Informed Consent: Patients must voluntarily enroll in the study, provide written informed consent, and be able to comply with the protocol-specified visits and procedures.

Who cannot join

  • Cardiovascular Disease: Baseline left ventricular ejection fraction (LVEF) < 55% assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan at screening, or any other significant cardiovascular disease, or myocardial disease classified as New York Heart Association (NYHA) Class III or IV.
  • Prior Ipsilateral Breast Cancer: History of ipsilateral invasive breast cancer.
  • Prior Treatment for Current Breast Cancer: Any prior chemotherapy, targeted therapy, and/or radiotherapy for the currently diagnosed breast cancer prior to enrollment.
  • Prior Immune Checkpoint Inhibitor Therapy: Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Prior TROP2/Topo I Inhibitor Therapy: Previous treatment with any TROP2-targeted therapy and/or topoisomerase I inhibitor.
  • Other Malignancies: History of other active malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
Show all 16Show fewer
  • Clinically Significant Pulmonary Impairment: Clinically significant pulmonary impairment due to concurrent pulmonary disease, including but not limited to: Any underlying pulmonary disease (e.g., pulmonary embolism within 3 months prior to treatment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) Any autoimmune, connective tissue, or inflammatory disease with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.)
  • History of pneumonectomy.
  • CYP3A4 Modulators: Requirement for strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first dose or during the study period (Concomitant use of strong CYP3A4 inhibitors or inducers is prohibited in this study; representative agents are listed in Appendix 2). All subjects must avoid concomitant use of any known CYP3A4-inducing drugs, herbal supplements, and/or food.
  • Contraindications/History: Known history of allergy/hypersensitivity to the study drugs or their components; history of immunodeficiency; history of organ transplantation.
  • Interstitial Lung Disease (ILD)/Pneumonitis: History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring systemic steroid therapy. Current ILD or non-infectious pneumonitis. Suspicious ILD or non-infectious pneumonitis on imaging at screening that cannot be ruled out by imaging evaluation.
  • Ocular Diseases: Documented severe dry eye syndrome, severe meibomian gland dysfunction and/or blepharitis, or history of corneal disease that may delay corneal epithelial healing.
  • Active Autoimmune Disease: Active autoimmune disease that has required systemic treatment within the past 2 years (Note: Hormone replacement therapy is not considered systemic treatment; e.g., type I diabetes, hypothyroidism managed with thyroid hormone replacement only, adrenal or pituitary insufficiency managed with physiologic corticosteroid replacement only).
  • Active Infection: Active infection requiring systemic therapy within 2 weeks prior to the first dose.
  • Uncontrolled Comorbidities: Any significant concurrent illness, in the investigator's judgment, that may jeopardize patient safety or affect study completion, including but not limited to uncontrolled hypertension, severe diabetes, active infection, etc.
  • Investigator Discretion: Any condition that, in the investigator's opinion, could interfere with the evaluation of the study drug, compromise patient safety, or interpretation of study results, or any other condition that makes the subject unsuitable for study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaosong Chen contact

+86-21-64370045-602102

chenxiaosong0156@hotmail.com

China1 site, 1 recruiting

  • Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

    Xiaosong Chen, +86-21-64370045-602102, xiaosongchen0156@hotmail.com

    Recruiting

Other trials in China

About this study

This study is a multicenter phase II trial planning to enroll 40 patients with primary triple-negative breast cancer (tumor size ≥2 cm, clinical lymph node stage cN0-3, M0). Participants will receive the combination therapy of Sac-TMT and KL-A167 during the neoadjuvant treatment phase. The study aims to evaluate the efficacy and safety of Sac-TMT combined with KL-A167 as neoadjuvant treatment for triple-negative breast cancer.

Conditions
Breast Cancer
Being tested
SKB264
Keywords
breast cancer, triple negative, Sac-TMT, SKB264, KL-A167, neoadjuvant
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SKB264Drug

    Also called KL-A167

    1. Neoadjuvant Treatment Phase Phase a: All eligible subjects will receive Sac-TMT (5 mg/kg, Day 1, every 2 weeks) combined with KL-A167 (900 mg, Day 1, every 2 weeks) for 6 cycles (12 weeks).

    At Week 12 (beginning of Week 13), radiographic assessment via contrast-enhanced breast MRI will be performed. Based on tumor response, patients proceed to Neoadjuvant Phase b:

    1. Responders (investigator-assessed Partial Response [PR] or Complete Response [CR]): Continue the same combination regimen for an additional 12 weeks of neoadjuvant therapy. ii. Non-responders (investigator-assessed Stable Disease [SD] or Progressive Disease [PD]): Switch to KL-A167 (900 mg every 2 weeks) combined with nab-paclitaxel (100 mg/m², Days 1, 8, 15, every 4 weeks per cycle) and carboplatin (AUC 2 mg·min/mL, Days 1, 8, 15, every 4 weeks per cycle) for 12 weeks.
Study groups in NCT07371208
Study groupRoleWhat they receive
Study cohortExperimentaltreatment arm
Receives: Drug: SKB264

What is being measured

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

  1. pCR

    ypT0/Tis ypN0

    Measured: after neoadjuvant treatment, at surgery

Secondary outcomes (4)

  1. ORR

    ORR per RECIST v1.1

    Measured: after neoadjuvant treatment, at surgery

  2. EFS

    EFS

    Measured: From enrollment to 5 years after surgery

  3. OS

    OS

    Measured: From enrollment to 5 years after surgery

  4. Safety

    Safety per NCI CTCAE 5.0

    Measured: through study completion, an average of 1 year

Timeline

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

  1. First posted27 Jan 2026
  2. Study start24 Dec 2025
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2030 (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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07371208
Sponsor's protocol ID
RJBC-2503
Other IDs
Shanghai Jiaotong University
Acronym
ST-A-TN
Status last verified
Jan 2026
First submitted
18 Jan 2026
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SKB264 in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine 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 9 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 27 Jan 2026. 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 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?

Contact Xiaosong Chen (+86-21-64370045-602102, chenxiaosong0156@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR (time frame: after neoadjuvant treatment, at surgery). 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 NCT07371208.

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 27 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in