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A Prospective, Single-arm, Phase II Clinical Trial of Becotatug Vedotin for Injection Combined With Pucotenlimab Injection as a First-line Treatment for Platinum-intolerant Advanced Head and Neck Squamous Cell Carcinoma

NCT07628855 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-05

No results posted yet for this study

Summary

This study is a randomized, open-label, multi-center phase II trial evaluating the efficacy and safety of the becotatug vedotin in combination with pucotenlimab regimen in patients with advanced head and neck squamous cell carcinoma who are intolerant to platinum-based therapy.

Conditions

  • HNPCC

Interventions

DRUG

Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb)

Becotatug Vedotin for Injection combined with Pucotenlimab Injection as first-line treatment

Sponsors & Collaborators

  • Affiliated Cancer Hospital of Shantou University Medical College

    collaborator OTHER

  • The University of Hong Kong-Shenzhen Hospital

    collaborator OTHER

  • Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-14
Primary Completion
2028-08-30
Completion
2028-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07628855 on ClinicalTrials.gov