drugset / Trial / NCT05472506

Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer

NCT05472506

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase 1b study in adult patients diagnosed with resistant or recurrent head and neck squamous cell carcinoma (HNSCC) designed to assess the safety and tolerability of IK-175 in combination with nivolumab. Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.

Timeline

Start
2023-03
Primary completion
2023-04
Completion
2023-04

Drugs

EvaluationDrugModalityDoseRoute
Subject IK-175 Unknown 450 mg Oral
Subject IK-175 Unknown 600 mg Oral
Background Nivolumab Monoclonal antibody