drugset / Trial / NCT03022409

A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC).

NCT03022409

Phase 1 Completed 21 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

Summary

This biomarker study has been designed to assess the effects of different agents in both tumour tissue and peripheral samples to help inform the best combinations of DDR agents with immuno-oncology (IO) therapies. In the first instance 2 DDR agents will be assessed separately as monotherapy. Additional arms may be added later to evaluate other DDR agents and/or DDR and immunotherapy agents in combination or in sequence. The primary objective of the study is to investigate immune activation due to DDR inhibition by assessing tumour and blood samples of patients treated with study investigational agent(s).

Timeline

Start
2017-09-18
Primary completion
2021-01-20
Completion
2021-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceralasertib Small molecule 160 mg Oral
Subject Olaparib Small molecule 300 mg Oral