CUE-101 for Throat Cancer

Overseen By Douglas R. Adkins

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Transplant history, Metastases, Cardiovascular disease, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 103

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CUE-101 to see if it is safe and effective for patients with a specific type of throat cancer. The treatment aims to boost the immune system before standard cancer therapy. Patients are newly diagnosed and have not yet received any other treatments.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have been treated with corticosteroids (more than 10 mg per day prednisone or equivalent) or other immune suppressive drugs within 14 days before starting the study drug.

Who Is on the Research Team?

Douglas R. Adkins

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinoma who are HLA-A*0201 positive. They should be able to undergo standard cancer treatments and have a good performance status (ECOG ≤ 1). Patients must not have had previous head and neck radiation, other cancers in the last two years (with some exceptions), or certain health conditions like uncontrolled hypertension or recent heart attacks.

Inclusion Criteria

My cancer is confirmed to be squamous-cell carcinoma in the throat or upper neck.

My cancer is stage I-III, but not the earliest stages of T1N0 or T2N0.

My tumor is HPV16 positive and shows high p16 protein levels.

Exclusion Criteria

I have had radiation therapy on my head or neck before.

I have a history of hepatitis B or C but have been in remission for over a year if treated.

History of prior allogeneic bone marrow, stem-cell or solid organ transplantation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

CUE-101 is administered in one of three schedules before standard of care therapy

2 weeks

Multiple visits for CUE-101 administration and assessments

Standard of Care Therapy

Participants undergo surgery and/or chemoradiation therapy as per standard of care

Varies based on treatment plan

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up visits at 2, 4, 8, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• CUE-101

Trial Overview The trial is testing three different schedules of CUE-101 given before standard cancer treatments to see how safe it is and if it shows signs of working against the cancer. CUE-101 will be administered during the neoadjuvant phase, which means before main treatment starts. Researchers will collect blood and tumor samples to look for changes after giving CUE-101.

How Is the Trial Designed?

Group I: Schedule C: CUE-101 Experimental Treatment 1 Intervention

* In Schedule C, CUE-101 will be administered during the neoadjuvant phase as a single dose given 7 days prior to initiation of standard of care (SOC) therapy. * Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy)

Group II: Schedule B: CUE-101 Experimental Treatment 1 Intervention

* In Schedule B, CUE-101 will be administered during the neoadjuvant phase as two doses: one dose given 14 days and one dose given 7 days prior to initiation of standard of care (SOC) therapy. * Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy)

Group III: Schedule A: CUE-101 Experimental Treatment 1 Intervention

* In Schedule A, CUE-101 will be administered during the neoadjuvant phase as a single dose given 14 days prior to initiation of standard of care (SOC) therapy. * Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy)

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Cue Biopharma

Industry Sponsor

Trials

3

Recruited

160+