drugset / Trial / NCT06597565

A Phase II Study of ACR-368 and Low Dose Gemcitabine in R/M HNSCC

NCT06597565

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to determine the activity and safety of ACR-368 (prexasertib) in combination with gemcitabine in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Participants will receive the study drugs ACR-368 and a low dose of gemcitabine once every 2 weeks in 4-week cycles and will continue on treatment unless the disease deteriorates.

Timeline

Start
2024-09-25
Primary completion
2028-08-23
Completion
2028-08-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Prexasertib Small molecule 105 mg/m2 Intravenous
Background Gemcitabine Small molecule 10 mg/m2 Intravenous