OncoMatch/Clinical Trials/NCT06597565
A Phase II Study of ACR-368 and Low Dose Gemcitabine in R/M HNSCC
Is NCT06597565 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Gemcitabine and ACR-368 for head and neck squamous cell carcinoma.
Treatment: Gemcitabine · ACR-368 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Allowed: CDKN2A p16 overexpression
Must have sufficient archived tumor tissue available for p16 immunohistochemistry (IHC) staining if the status is unknown.
Allowed: HPV HPV-positive
HPV status determined by HPV DNA sequencing, HPV DNA/RNA in situ hybridization, or equivalent assays using tumor tissue or cell free HPV DNA testing or equivalent using blood-based assays are also acceptable.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — R/M
Must have been treated with one prior line of PD-1/PD-L1 inhibitor with/without chemotherapy.
Cannot have received: systemic therapy
Exception: No prior systemic therapy for 4 weeks from the time of the study treatment.
Patients should not have any prior systemic therapy for 4 weeks from the time of the study treatment.
Cannot have received: palliative radiation therapy
Exception: No palliative radiation therapy for 2 weeks from the time of the study treatment. Palliative radiation therapy is permitted during the study treatment if it does not involve target lesions.
Patients should not have any palliative radiation therapy for 2 weeks from the time of the study treatment. Palliative radiation therapy is permitted during the study treatment if it does not involve target lesions.
Lab requirements
Blood counts
Must meet the laboratory criteria outlined in the protocol. Blood transfusion and/or blood product support are allowed.
Kidney function
Must meet the laboratory criteria outlined in the protocol.
Liver function
Must meet the laboratory criteria outlined in the protocol.
Cardiac function
LVEF < 45% or NYHA Class 2 or higher excluded. Cardiovascular disease defined as: uncontrolled hypertension >160/90 mmHg, history of torsades de pointes, significant ECG abnormalities, unstable cardiac arrhythmia, pathologic symptomatic bradycardia, left bundle branch block, second degree AV block type II, third degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia, congenital long QT syndrome, prolonged QT interval due to medications, QTc > 450 msec (men) or > 470 msec (women), symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction < 20%, TIA, or CVA within 6 months of Day 1).
Must meet the laboratory criteria outlined in the protocol. LVEF < 45% or NYHA Class 2 or higher excluded. Cardiovascular disease defined as: ... (see above for full details).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify