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

NCT07668154 | Not Yet Recruiting Phase 2

• 1 other identifier: SKB571-II-06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 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.

Conditions

HNSCC

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.

Study Arms (1)

SKB571

EXPERIMENTAL

intravenous infusion, q3w

Drug: SKB571

Interventions

SKB571 DRUG

SKB571

SKB571

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (2)

West China Hospital, Sichuan University

Chengdu, China

Location

Shanghai Oriental Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Xin Li

  Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Xin Li

CONTACT

+86 10 58302512; lixin@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 25, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)