drugset / Trial / NCT07668154

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

NCT07668154 ↗

Phase 2 Recruiting 120 enrolled Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-07-27
Primary completion
2028-09-30
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — Intravenous
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject SKB571 Unknown — —