Actively Recruiting
A Phase II Study of ACR-368 and Low Dose Gemcitabine in R/M HNSCC
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2025-10-20
43
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
A
Acrivon Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Phase II Study of ACR-368 and Low Dose Gemcitabine in R/M HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient (or legally authorized representative) must understand and voluntarily sign informed consent.
- Must be able and willing to comply with study visits and protocol requirements.
- Must have sufficient archived tumor tissue available for p16 immunohistochemistry or HPV testing.
- Must have sufficient archived tumor tissue less than 3 months old for OncoSignature determination or agree to a fresh biopsy.
- Must agree to biopsies after lead-in infusion and at disease progression or end of treatment.
- Must have recurrent or metastatic head and neck squamous cell carcinoma including oral cavity, oropharynx, larynx, hypopharynx, or p16/HPV-positive unknown primary.
- Must have been treated with one prior line of PD-1/PD-L1 inhibitor with or without chemotherapy, or be immunotherapy ineligible due to autoimmune disease or steroid use.
- Must have at least one measurable lesion per RECIST v1.1.
- Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Must meet laboratory criteria outlined in the protocol; blood transfusions and support allowed.
- Patients of childbearing potential and their partners must agree to use highly effective birth control during and for 1 year after treatment.
You will not qualify if you...
- Patients must not have had any prior systemic therapy within 4 weeks before study treatment.
- Patients must not have had palliative radiation therapy within 2 weeks before study treatment, except if it does not involve target lesions.
- Patients with therapy-related toxicities greater than Grade 1 per NCI CTCAE v5.0 are excluded except for dysphagia, alopecia, or vitiligo.
- Patients with symptomatic or untreated brain metastases are excluded; treated brain metastases must be stable for at least 2 weeks and asymptomatic.
- Patients with left ventricular ejection fraction below 45% or New York Heart Association Class 2 or higher are excluded.
- Patients with uncontrolled hypertension, significant ECG abnormalities, symptomatic heart failure, unstable angina, recent myocardial infarction, or severe cardiovascular disease are excluded.
- Patients with another primary malignancy within the past 3 years are excluded except certain low-risk cancers.
- Pregnant, breastfeeding women, or persons unable to consent without a legally authorized representative are excluded.
- Patients in emergency situations unable to consent without a legally authorized representative are excluded.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
K
Kara Hoffman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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