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Anti-cancer agent

ACR-368 + Gemcitabine for Head and Neck Cancer

Phase 2
Recruiting
Led By Christine Chung, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see how well ACR-368 (prexasertib) works with gemcitabine in patients with Head and Neck Squamous Cell Carcinoma. Patients will receive

Who is the study for?
This trial is for individuals with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). Participants should not have had previous chemotherapy for their recurrent/metastatic disease, must be able to receive medication intravenously, and have measurable disease as per RECIST criteria. Key exclusions include prior treatment with ACR-368 or gemcitabine in the metastatic setting, active infections, significant cardiovascular disease, or other serious medical conditions.
What is being tested?
The study is testing the effectiveness and safety of a combination therapy: ACR-368 (prexasertib) alongside low dose gemcitabine. Patients will be treated every two weeks over four-week cycles. The goal is to see how well this combo works against HNSCC compared to standard treatments.
What are the potential side effects?
Potential side effects may include fatigue, nausea, hair loss from gemcitabine; increased risk of infection due to lowered white blood cell counts; and possible liver enzyme changes. Side effects specific to ACR-368 are not detailed but could overlap with those known from similar drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate: Cohort A
Overall Response Rate: Cohort B
Secondary study objectives
Duration of response (DOR)
Overall Survival (OS)
Progression Free Survival (PFS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B (p16/HPV-pos)Experimental Treatment2 Interventions
Participants with p16/HPV-positive R/M HNSCC will be assigned to Cohort B. Participants will be administered lead-in low dose gemcitabine (LDG) 10 mg/m2 IV Day -7 (+/- 3 days, before Cycle 1 only) followed by ACR-368 105 mg/m2 IV every 2 weeks and LDG 10 mg/m2 every 2 weeks until discontinuation due to disease progression, intolerability, or consent withdrawal. When delay or discontinuation of the treatment is necessary, both ACR-368 and LDG will be delayed or discontinued together.
Group II: Cohort A (p16/HPV-neg)Experimental Treatment2 Interventions
Participants with p16/HPV-negative recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) will be assigned to Cohort A. Participants will be administered lead-in low dose gemcitabine (LDG) 10 mg/m2 IV Day -7 (+/- 3 days, before Cycle 1 only) followed by ACR-368 105 mg/m2 IV every 2 weeks and LDG 10 mg/m2 every 2 weeks until discontinuation due to disease progression, intolerability, or consent withdrawal. When delay or discontinuation of the treatment is necessary, both ACR-368 and LDG will be delayed or discontinued together.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
559 Previous Clinical Trials
144,554 Total Patients Enrolled
Acrivon TherapeuticsIndustry Sponsor
1 Previous Clinical Trials
390 Total Patients Enrolled
Christine Chung, MDPrincipal InvestigatorMoffitt Cancer Center
5 Previous Clinical Trials
183 Total Patients Enrolled
~29 spots leftby Aug 2028
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