drugset / Trial / NCT07408063

A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Resistance in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT07408063

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The BeeHive study is an investigator-initiated, single center, open-label phase II clinical trial that is designed to conduct a comprehensive multiomic biomarker evaluation across two single-arm cohorts to elucidate mechanisms of response and resistance in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). It is anticipated that about 20 patients will be enrolled in Cohort A and an additional of 10 patients will be enrolled in Cohort B.

Timeline

Start
2026-04-27
Primary completion
2030-06-30
Completion
2031-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dostarlimab Monoclonal antibody 500 mg Intravenous
Subject HS-20093 Other / unclassified 8 mg/kg Intravenous