A Phase II Study to Evaluate the Efficacy and Safety of SKB571 in Recurrent or Metastatic HNSCC Participants
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
1 other identifier
interventional
120
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedStudy Start
First participant enrolled
July 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
September 9, 2026
August 1, 2026
2.2 years
June 16, 2026
September 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR) of SKB571
ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Up to approximately 24 months.
Secondary Outcomes (12)
Progression-free survival (PFS)
Up to approximately 24 months.
Duration of Response (DOR)
Up to 24 months
Disease control rate (DCR)
Up to 24 months
Overall Survival (OS)
Up to 24 months
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Up to approximately 24 months.
- +7 more secondary outcomes
Study Arms (3)
Cohort 1 - SKB571 monotherapy
EXPERIMENTALCohort 2 - SKB571 + pembrolizumab combination therapy
EXPERIMENTALCohort 3 - SKB571 + pembrolizumab + platinum-based combination therapy
EXPERIMENTALInterventions
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).
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.
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.
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Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
West China Hospital, Sichuan University
Chengdu, China
Shanghai Oriental Hospital
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xin Li
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2026
First Posted
June 25, 2026
Study Start
July 27, 2026
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
September 9, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share