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HNSCCPhase 2NCT07668154

A Phase II Study to Evaluate the Efficacy and Safety of SKB571 in Recurrent or Metastatic HNSCC Participants

A Phase 2 study testing SKB571, Pembrolizumab and carboplatin in people with HNSCC, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites 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 multicenter, open-label, Phase II clinical study to assess the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with recurrent or metastatic HNSCC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HNSCC
What is being tested?
SKB571, Pembrolizumab and carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesChina
Study dates
27 Jul 2026to 31 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

  • Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form.
  • Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is not curable by local therapy and not amenable to curative surgery, with the primary tumor located in the oral cavity, oropharynx, hypopharynx, or larynx.
  • Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before the first dose.
  • Participants who have adequate bone marrow, liver, kidney, and coagulation function.
  • Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.
  • Participants must voluntarily join this study, sign the informed consent form (ICF), and be able to comply with the visits and related procedures specified in the protocol.

Who cannot join

  • History or current metastases to central nervous system.
  • Subjects with other malignant tumors within 3 years prior to the first dose.
  • Presence of any cardiovascular and cerebrovascular disorders or risk factors.
  • Presence of uncontrolled systemic disease.
  • Presence of clinically symptomatic or uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • History of interstitial lung disease (ILD) or non-infectious pneumonitis.
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  • Presence within 3 months before the first dose of other moderate to severe lung disorders.
  • Tumor invasion or compression of surrounding vital organs and major blood vessels.
  • Unresolved toxicity from prior anti-tumor therapy.
  • Serious infection within 4 weeks before the first dose.
  • Presence of active HIV, hepatitis B or hepatitis C or co-infection with HBV and HCV.
  • Known active pulmonary tuberculosis.
  • Known history of allogeneic organ transplant or hematopoietic stem cell transplant.
  • History of allergy to any component of the study drug or severe hypersensitivity to other monoclonal antibodies.
  • Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
  • Participants who have received other investigational drug treatments within 4 weeks before the first dose.
  • Prior vaccination with a therapeutic anti-tumor vaccine, or any live vaccine within 4 weeks before the first dose, or planned vaccination with a live vaccine during the study.
  • Participants who received systemic corticosteroid therapy with >10 mg/day of prednisone or other immunosuppressive drugs within 2 weeks before the first dose.
  • Received strong inhibitors or strong inducers of cytochrome P450 (CYP3A4) or breast cancer resistance protein (BCRP) inhibitors within 2 weeks prior to the first dose or within 5 half-lives of the known drug (whichever is longer).
  • Pregnant or breastfeeding women.
  • Known history of psychosis or drug abuse that prevents the participant from cooperating with the study.
  • Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to higher medical risk and/or uncertainty in survival assessment, or may affect protocol compliance.
  • Any condition that, in the investigator's opinion, interferes with the evaluation of the investigational product, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.

Trial locations and contacts

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

Xin Li contact

+86 10 58302512

lixin@kelun.com

China2 sites, 2 recruiting

  • West China Hospital, Sichuan University

    Chengdu

    Li Zheng, +86 28 85422707, huaxigcp@163.com

    Lei Liu

    Recruiting

  • Shanghai Oriental Hospital

    Shanghai

    Yan Shi, + 86 21 38804518, austainsy@163.com

    Ye Guo

    Recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a multicenter, open-label, Phase II clinical study to assess the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with recurrent or metastatic HNSCC.

Conditions
HNSCC
Being tested
SKB571, Pembrolizumab, carboplatin, Cisplatin
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • SKB571Drug

    q3w

  • PembrolizumabDrug

    Pembrolizumab will be administered by intravenous infusion at a dose of 200 mg on Day 1 of each 3-week cycle, for a maximum treatment duration of 35 cycles (approximately 24 months).

  • carboplatinDrug

    Carboplatin will be administered by intravenous infusion at a dose of AUC 5 mg/mL/min on Day 1 of each 3-week cycle (maximum dose of carboplatin not to exceed 750 mg), for a maximum of 6 cycles.

  • CisplatinDrug

    Cisplatin will be administered by intravenous infusion at a dose of 75 mg/m2 on Day 1 of each 3-week cycle, for a maximum of 6 cycles.

Study groups in NCT07668154
Study groupRoleWhat they receive
Cohort 1 - SKB571 monotherapyExperimentalNot described
Receives: Drug: SKB571
Cohort 2 - SKB571 + pembrolizumab combination therapyExperimentalNot described
Receives: Drug: SKB571; Drug: Pembrolizumab
Cohort 3 - SKB571 + pembrolizumab + platinum-based combination therapyExperimentalNot described
Receives: Drug: SKB571; Drug: Pembrolizumab; Drug: carboplatin; Drug: Cisplatin

What is being measured

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

  1. Objective response rate (ORR) of SKB571

    ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Up to approximately 24 months.

Secondary outcomes (12)

  1. Progression-free survival (PFS)

    Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.

    Measured: Up to approximately 24 months.

  2. Duration of Response (DOR)

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

    Measured: Up to 24 months

  3. Disease control rate (DCR)

    Assessed by the investigators as per RECIST v1.1

    Measured: Up to 24 months

  4. Overall Survival (OS)

    Time from start of treatment to death due to any reason.

    Measured: Up to 24 months

  5. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results.

    Measured: Up to approximately 24 months.

  6. Maximum Plasma Concentration (Cmax) of SKB571-ADC

    Blood Samples will be collected to determine the Cmax of SKB571-ADC in the plasma.

    Measured: Up to approximately 24 months.

  7. Minimum Plasma Concentration(Cmin) of SKB571-ADC

    Blood samples will be collected to determine the Cmin of SKB571-ADC in the plasma.

    Measured: Up to approximately 24 months

  8. Maximum Plasma Concentration(Cmax) of SKB571-TAb

    Blood samples will be collected to determine the Cmax of SKB571-TAb in the plasma.

    Measured: Up to approximately 24 months

  9. Minimum Plasma Concentration(Cmin) of SKB571-TAb

    Blood samples will be collected to determine the Cmin of SKB571-TAb in the plasma.

    Measured: Up to approximately 24 months

  10. Maximum Plasma Concentration (Cmax) of unconjugated KL610348

    Blood Samples will be collected to determine the Cmax of unconjugated KL610348 in the plasma.

    Measured: Up to approximately 24 months

  11. Minimum Plasma Concentration(Cmin) of unconjugated KL610348

    Blood Samples will be collected to determine the Cmin of unconjugated KL610348 in the plasma.

    Measured: Up to approximately 24 months

  12. Immunogenicity of SKB571

    Incidence of anti-drug antibody (ADA) against SKB571.

    Measured: Up to approximately 24 months.

Timeline

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

  1. First posted25 Jun 2026
  2. Study start27 Jul 2026
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion31 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07668154
Sponsor's protocol ID
SKB571-II-06
Status last verified
Aug 2026
First submitted
16 Jun 2026
Last updated
9 Sep 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 2 study testing SKB571, Pembrolizumab and carboplatin in people with HNSCC, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites 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 7 inclusion and 23 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Xin Li (+86 10 58302512, lixin@kelun.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) of SKB571 (time frame: Up to approximately 24 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 NCT07668154.

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 9 Sep 2026.

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