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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title A Phase II Study of ACR-368 and Low Dose Gemcitabine in R/M HNSCC
ClinicalTrials.gov ID: NCT06597565
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, being studied as a potential treatment for head and neck squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient (or a legally authorized representative) must understand and voluntarily sign informed consent prior to any study-related...
- Must be able and willing to comply with the study visit schedule and protocol requirements.
- Must have sufficient archived tumor tissue available for p16 immunohistochemistry (IHC) staining if the status is unknown. HPV status determined by...
- Must have sufficient archived tumor tissue available for OncoSignature determination. The tumor tissue must be less than 3 months old from the...
- Must agree to a biopsy after the lead-in LDG infusion and at the time of disease progression (or end of treatment if applicable).
You likely can't join if
- Patients should not have any prior systemic therapy for 4 weeks from the time of the study treatment.
- Patients should not have any palliative radiation therapy for 2 weeks from the time of the study treatment. Palliative radiation therapy is permitted...
- Patients with prior therapy-related toxicities Grade \>1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)...
- Patients with symptomatic and/or untreated brain metastases (of any size and any number). Patients with definitively treated brain metastases may be...
- Patients who have a left ventricular ejection fraction (LVEF) \< 45% or who are New York Heart Association (NYHA) Class 2 or higher.
- Patients with cardiovascular disease defined as: A) Uncontrolled hypertension defined as blood pressure \> 160/90 mmHg at Screening confirmed by...
See the full eligibility criteria
- Patient (or a legally authorized representative) must understand and voluntarily sign informed consent prior to any study-related assessments/procedures being conducted.
- Must be able and willing to comply with the study visit schedule and protocol requirements.
- Must have sufficient archived tumor tissue available for p16 immunohistochemistry (IHC) staining if the status is unknown. HPV status determined by HPV DNA sequencing, HPV DNA/RNA in situ hybridization, or equivalent...
- Must have sufficient archived tumor tissue available for OncoSignature determination. The tumor tissue must be less than 3 months old from the enrollment date. There should not be any intervening systemic therapy from...
- Must agree to a biopsy after the lead-in LDG infusion and at the time of disease progression (or end of treatment if applicable).
- Must have R/M HNSCC including oral cavity, oropharynx, larynx, and hypopharynx. Patients with p16-positive or HPV-positive unknown primary of head and neck are eligible.
- Must have been treated with one prior line of PD-1/PD-L1 inhibitor with/without chemotherapy. Patients who are immunotherapy ineligible due to history of autoimmune disease or steroid requirement (prednisone \>10mg per...
- Must have at least one measurable lesion as defined by RECIST v1.1.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Must meet the laboratory criteria outlined in the protocol. Blood transfusion and/or blood product support are allowed.
- Patients of childbearing potential and patients whose sexual partners are of childbearing potential must be willing to practice an approved method of highly effective birth control with their partners starting at the...
- Patients should not have any prior systemic therapy for 4 weeks from the time of the study treatment.
- 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.
- Patients with prior therapy-related toxicities Grade \>1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0; except for dysphagia, alopecia, or vitiligo...
- Patients with symptomatic and/or untreated brain metastases (of any size and any number). Patients with definitively treated brain metastases may be eligible, must be stable for at least 2 weeks and must be asymptomatic...
- Patients who have a left ventricular ejection fraction (LVEF) \< 45% or who are New York Heart Association (NYHA) Class 2 or higher.
- Patients with cardiovascular disease defined as: A) Uncontrolled hypertension defined as blood pressure \> 160/90 mmHg at Screening confirmed by repeat (medication permitted). B) History of torsades de pointes...
- Patients who have had another primary malignancy within the previous 3 years (except for those who do not require treatment or have been curatively treated \>1 year ago, and in the judgment of the Investigator, do not...
- Patients who are of the following protected classes will be excluded: Pregnant, parturient, or breastfeeding women. Persons who are hospitalized without consent or those deprived of liberty because of a judiciary or...
- Patients in emergency situations who cannot consent to the study and for whom a legally authorized representative is not available.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.