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Breast CancerPhase 2NCT07258108

Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors

A Phase 2 study testing Lucanisatuzumab plus tagolimumab in people with Breast Cancer, run by Sun Yat-sen University 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
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Trial summary

This is a Phase II single-arm study designed to evaluate the efficacy and safety of Sac-TMT + KL-A167 in 35 patients with PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor. The primary endpoint is the 6-month PFS rate. 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?
Lucanisatuzumab plus tagolimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
13 Nov 2025to 30 Dec 2028
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 years old.
  • HR+/HER2- breast cancer (BC), meeting the following conditions:
  • HR+/HER2-; HER2-(IHC 0 or 1+); IHC 2+(FISH negative); HR+ (ER and/or PR IHC showed ≥1%);
  • Tumor stage: Locally advanced, recurrent, or metastatic HR+/HER2- breast cancer; 3) Disease progression during or within 12 months after completion of adjuvant endocrine therapy based on a CDK4/6 inhibitor, or disease progression on CDK4/6 inhibitor treatment for metastatic disease; 4) PD-L1 positive (CPS ≥ 1); 5) At least one measurable target lesion as assessed by the investigator per RECIST 1.1; 6) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy more than 12 weeks; 7) Adequate organ function, defined as:
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  • Complete blood count: Neutrophil count ≥ 1.5×10^9/L; platelets ≥ 100×10^9/L; hemoglobin ≥ 9 g/dL.
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  • Liver function: AST, ALT, and ALP ≤ 2.5× ULN; total bilirubin ≤ 1.5× ULN; ALT and AST ≤ 5× ULN, TBIL ≤ 2× ULN for patients with liver metastases; ALP ≤ 5× ULN for patients with liver or bone metastases.
  • Renal function: Creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula).
  • Coagulation function: INR, APTT, and PT ≤ 1.5× ULN.
  • Cardiac function: ECHO or MUGA scan indicating LVEF ≥ 50%. 8) For female participants of childbearing potential and male participants with reproductive potential, effective medical contraceptive measures must be implemented from the time of signing the informed consent until six months after the last administration; 9) Voluntary participation in the study with signed informed consent, demonstrated good compliance, and willingness to follow up as required.

Who cannot join

  • Received any of the following treatments during the advanced stage:
  • .Chemotherapy;
  • .any targeted therapy against topoisomerase I including antibody-drug conjugates (ADCs);
  • . immune checkpoint agonists (e.g., anti-PD-1/L1antibodies, anti-CTLA-4 antibodies), or any immune cell therapy;
  • Recurrence or metastasis within 12 months of the last chemotherapy in the early stage;
  • Subjects with central nervous system (CNS) metastases. For subjects with brain metastases who have previously received local therapy,
  • Other malignancies within 5 years prior to dosing (excluding locally treated and cured tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ);

Trial locations and contacts

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

Fei Xu, MD contact

+86-13711277870

xufei@sysucc.org.cn

Kuikui Jiang, MD contact

+86-15210589011

jiangkk@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Fei Xu, MD, +86-13711277870, xufei@sysucc.org.cn

    Kuikui Jiang, MD, +86-15210589011, jiangkk@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase II Study of Sacituzumab Tirumotecan (Sac-TMT) Combined With Tagitanlimab(KL-A167) in PD-L1-Positive, Hormone Receptor-Positive/HER2-Negative Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors

This is a Phase II single-arm study designed to evaluate the efficacy and safety of Sac-TMT + KL-A167 in 35 patients with PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor. The primary endpoint is the 6-month PFS rate. Treatment will continue until disease progression or intolerable toxicity, with periodic imaging assessments and survival follow-up.

Read the detailed description

This study is a prospective, single-arm, multicenter Phase II study designed to evaluate the efficacy and safety of Sac-TMT in combination with KL-A167 for the treatment of PD-L1-positive, HR+/HER2- metastatic breast cancer patients who previously treated with CDK4/6.

The study plans to enroll 35 patients. The primary endpoint is the 6-month progression-free survival (PFS) rate assessed by the investigator (RECIST v1.1). Secondary endpoints include PFS, objective response rate (ORR), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety. An exploratory endpoint is to analyze the correlation between TROP2 and PD-L1 expression and efficacy.

The treatment regimen consists of intravenous administration of Sac-TMT (5 mg/kg, Q2W) combined with KL-A167 (900 mg, Q2W). Treatment will continue until disease progression or occurrence of intolerable toxicity. Tumor assessments will be conducted every 6 weeks for the first 6 months, followed by every 12 weeks thereafter. Safety follow-up will occur after treatment completion, with telephone follow-ups every 3 months to collect survival and subsequent treatment information.

Conditions
Breast Cancer
Being tested
Lucanisatuzumab plus tagolimumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Lucanisatuzumab plus tagolimumabDrug

    Each participant receives Lucanisatuzumab plus tagolimumab intravenously.

Study groups in NCT07258108
Study groupRoleWhat they receive
Sacituzumab Tirumotecan(Sac-TMT) plus Tagitanlimab(KL-A167)ExperimentalSac-TMT (5 mg/kg, Q2W) in combination with KL-A167 (900 mg, Q2W) administered intraveno
Receives: Drug: Lucanisatuzumab plus tagolimumab

What is being measured

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

  1. 6-month progression-free survival rate (PFS)

    The proportion of subjects who remained free of radiographic disease progression or death within 6 months of receiving the first dose of study treatment, relative to the total number of subjects.

    Measured: 6 months

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    The proportion of subjects achieving complete response (CR) or partial response (PR) relative to the total number of subjects

    Measured: 1 year

  2. Progression-Free Survival (PFS)

    The time from the first administration of study treatment to the first occurrence of radiographic disease progression or death, whichever occurs first

    Measured: 1 year

  3. Disease Control Rate (DCR)

    The proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) relative to the total number of subjects

    Measured: 1 year

  4. Duration of Response (DoR)

    The time interval from the first documented disease response to disease progression or death (whichever occurs first)

    Measured: 1 year

  5. Overall survival (OS)

    The time from the first administration of the study treatment to the participant's death from any cause

    Measured: 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 posted2 Dec 2025
  2. Study start13 Nov 2025
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Dec 2028 (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
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07258108
Sponsor's protocol ID
SYSU-2025
Status last verified
Nov 2025
First submitted
20 Nov 2025
Last updated
8 May 2026
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 Lucanisatuzumab plus tagolimumab in people with Breast Cancer, run by Sun Yat-sen University 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 10 inclusion and 7 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 8 May 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 Fei Xu, MD (+86-13711277870, xufei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month progression-free survival rate (PFS) (time frame: 6 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 NCT07258108.

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 8 May 2026.

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