NCT06597565

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

A Phase II Study of ACR-368 and Low Dose Gemcitabine Combination Therapy in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine is a standard of care given at ultralow dose in combination with the experimental drug ACR-368.
DRUG	ACR-368	ACR-368 is an experimental drug.

Timeline

• Start date: 2024-09-25
• Primary completion: 2028-08-23
• Completion: 2028-08-23
• First posted: 2024-09-19
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study