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

NCT06597565 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-10-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Acrivon Therapeutics

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Christine Chung, MD · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2028-08-23
Completion
2028-08-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06597565 on ClinicalTrials.gov