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Breast CancerPhase 1/2NCT07774624

Study of SKB103 in HER2-negative Breast Cancer

A Phase 1/2 study testing SKB103 monotherapy in people with Breast Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd..

Not yet recruiting

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

Sites and contacts
Official record
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Trial summary

This is a Phase I/II clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced (locally advanced, recurrent, or metastatic) HER2-negative breast cancer. The study includes a Phase 1 dose escalation stage and a Phase 2 indication expansion stage. 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?
SKB103 monotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
31 Aug 2026to 31 Dec 2030
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willingness to participate in the study, sign the informed consent form(ICF), and comply with the protocol-specified visits and relevant procedures.
  • Aged ≥ 18 and ≤ 75 years at the time of signing ICF.
  • Histologically and/or cytologically confirmed HER2-negative Breast cancer who have failed standard therapy.
  • Participants should provide tumor tissue samples for biomarker testing as much as possible.
  • At least one measurable lesion per RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) score is 0 or 1.
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  • Life expectancy ≥ 12 weeks.
  • Acceptable bone marrow and organ function.
  • Male and female participants must agree to use highly effective contraceptive methods during the study period.

Who cannot join

  • Participants with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, and active central nervous system (CNS) metastases.
  • Participants with other malignant tumors within 3 years prior to the first administration.
  • Presence of any serious cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
  • Presence of any uncontrolled systemic disease, as judged by the investigator.
  • Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
  • History of interstitial lung disease or noninfectious pneumonitis.
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  • Other lung diseases that may interfere with drug-related pulmonary toxicity or may cause clinically serious lung injuries.
  • Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disorders that prevent/delay corneal healing.
  • Presence of risk of developing esophagotracheal fistula or esophageal pleural fistula, or tumor invasion or compression of surrounding vital organs and major blood vessels with related clinical symptoms.
  • Clinical symptoms of intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess within 3 months prior to the first administration.
  • Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
  • Has experienced immune-related adverse events (irAE) of Grade 3 or higher during prior immunotherapy
  • Serious infection occurred within 4 weeks prior to the first administration.
  • Active hepatitis B or hepatitis C.
  • Positive result of human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.
  • Known active pulmonary tuberculosis.
  • Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.
  • History of allergies to any component of SKB103 injection, or severe hypersensitivity reaction to other monoclonal antibodies.
  • Has received prior antibody or drug therapy targeting T-cell co-stimulatory or checkpoint pathways, or cell therapy.
  • Received chemotherapy, immunotherapy, biological therapy, or other large molecule anti-tumor drugs within 4 weeks prior to the first administration.
  • Has received radiation therapy to lung lesions with a total dose >30 Gy within 6 months prior to the first dose of study drug.
  • Participants who received major surgeries 4 weeks prior to the first administration.
  • Participants who received other investigational drugs within 4 weeks prior to their first administration.
  • Participants who have previously received anti-tumor vaccines or have received any live vaccines within 4 weeks prior to the first administration or scheduled to receive live vaccines during study treatment.
  • Receipt of systemic corticosteroid therapy (>10mg of prednisone or its equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose.
  • Receipt of strong inhibitors or inducer of cytochrome P450（CYP3A4） or inhibitors of breast cancer resistance protein (BCRP) within 2 weeks prior to the first administration or within 5 half-lives of the known drugs(whichever is longer).
  • Pregnant or lactating women.
  • Known history of psychiatric disorder or substance abuse that may interfere with study compliance.
  • Has any local or systemic condition (non malignant or tumor related) that may impair protocol compliance.
  • Any condition that, in the opinion of the Investigator, may interfere with the evaluation of the study drug, participant safety, or interpretation of the study results; or any other condition that the investigator deems unsuitable for participation in this study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yina Diao contact

86-028-67252634

diaoyina@kelun.com

About this study

Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB103 in Participants With Locally Advanced, Recurrent, or Metastatic HER2-negative Breast Cancer.

This is a Phase I/II clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced (locally advanced, recurrent, or metastatic) HER2-negative breast cancer. The study includes a Phase 1 dose escalation stage and a Phase 2 indication expansion stage.

Read the detailed description

This is a multi-center, open-label, phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of SKB103 in participants with locally advanced, recurrent or metastatic HER2-negative breast cancer.

The study includes a Phase 1 dose escalation stage and a Phase 2 indication expansion stage.

Conditions
Breast Cancer
Being tested
SKB103 monotherapy
Keywords
HER2-negative Breast Cancer, Breast Cancer, SKB103
Medical subject headings
Breast Neoplasms

What participants receive

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

  • SKB103 monotherapyDrug

    SKB103 for injection, administered as monotherapy via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks, Q3W). Treatment continues until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death, whichever occurs first.

Study groups in NCT07774624
Study groupRoleWhat they receive
Participant GroupExperimentalNot described
Receives: Drug: SKB103 monotherapy

What is being measured

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

  1. Number of subjects achieving Dose-limiting toxicity (DLT)

    DLT is defined as any adverse event (AE) that meets protocol-defined DLT criteria, occurring in the first 21 days, and considered at least possibly drug-related.

    Measured: Within the first 21 days following the initial dose.

  2. Objective response rate(ORR)

    ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) as the best overall response assessed per RECIST 1.1.

    Measured: Up to approximately 3 years

Secondary outcomes (7)

  1. Progression-free survival (PFS)

    PFS is defined as the time from the first dose to progressive disease (PD) or death, whichever occurs first. PD will be assessed per RECIST 1.1.

    Measured: Up to approximately 3 years

  2. Duration of Response (DOR)

    Time from the start of the first assessment of CR or PR in participants to PD or death due to any reason.

    Measured: Up to approximately 3 years

  3. Disease control rate (DCR)

    DCR is defined as the proportion of participants with CR, PR or stable disease (SD) as the best overall response assessed per RECIST 1.1.

    Measured: Up to approximately 3 years

  4. Overall Survival (OS)

    Time from start of treatment to death due toany reason.

    Measured: Up to approximately 3 years

  5. Cmax

    Maximum Plasma Concentration (Cmax) of SKB103-ADC, SKB103-TAB, and free KL610348.

    Measured: Up to approximately 3 years

  6. Cmin

    Minimum Observed Plasma Concentration (Cmin) of SKB103-ADC, SKB103-TAB, and free KL610348.

    Measured: Up to approximately 3 years

  7. Immunogenicity

    Presence of Anti-drug antibodys (ADAs) for SKB103

    Measured: Up to approximately 3 years

Timeline

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

  1. First posted19 Aug 2026
  2. Study start31 Aug 2026 (estimated)
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07774624
Sponsor's protocol ID
SKB103-I/II-02
Status last verified
Jul 2026
First submitted
12 Aug 2026
Last updated
19 Aug 2026
Results posted
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 1/2 study testing SKB103 monotherapy in people with Breast Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd..

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 30 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 19 Aug 2026. 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 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 Yina Diao (86-028-67252634, diaoyina@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects achieving Dose-limiting toxicity (DLT) (time frame: Within the first 21 days following the initial dose.). 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?

On the ClinicalTrials.gov record for NCT07774624.

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 19 Aug 2026.

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