CUE-101 for Throat Cancer

Recruiting at 1 trial location

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 for individuals with a type of throat cancer linked to HPV16. The researchers aim to determine the safety and effectiveness of CUE-101 when administered before standard cancer treatments like surgery, chemotherapy, and radiation. Three different schedules for taking CUE-101 are being evaluated to identify the most effective one. This trial may suit someone newly diagnosed with HPV16-related throat cancer who hasn't started treatment and has a specific genetic marker (HLA-A*0201) identified through a blood test. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that CUE-101 is likely to be safe for humans?

Research has shown that CUE-101 is generally safe for people. One study found that taking CUE-101 before starting regular cancer treatments was safe and manageable. Patients received CUE-101 either once, 14 days before treatment, or twice, at 14 and 7 days before treatment. In both cases, patients handled the treatment well.

Early studies also showed that using CUE-101 alone was safe and had promising effects against cancer. These findings suggest that CUE-101 could be a safe option for those considering joining a clinical trial for throat cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for throat cancer?

Unlike the standard treatments for throat cancer, which typically include surgery, chemotherapy with cisplatin, and radiation, CUE-101 is designed to work differently. CUE-101 is an immunotherapy treatment that aims to activate the body's immune system specifically to target and fight cancer cells. Researchers are particularly excited about CUE-101 because it can be administered in different schedules before starting standard treatments, potentially priming the immune system to enhance the effectiveness of surgery and chemotherapy. This approach could lead to more effective and personalized treatment options for patients with throat cancer.

What evidence suggests that CUE-101 might be an effective treatment for throat cancer?

Research has shown that CUE-101 may help treat a type of throat cancer linked to HPV16. In earlier studies, patients who received CUE-101 with pembrolizumab had an 88% chance of surviving at least 12 months and lived an average of 32 months. This suggests that CUE-101 might extend patients' lives. Additionally, CUE-101 was well tolerated, causing no serious side effects. The treatment also activated the immune system, indicating it might help the body fight cancer. In this trial, participants will receive CUE-101 on different schedules to evaluate its effectiveness and safety. These findings offer hope that CUE-101 could be an effective treatment option for throat cancer. ^{1 3 6 7 8}

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+

Citations

1. targetedonc.com targetedonc.com/view/cue-101-pembrolizumab-shows-promising-response-survival-in-first-line-hpv-hnscc

CUE-101/Pembrolizumab Shows Promising Response ... The 12-month overall survival (OS) rate was 88%, and median OS reached 32 months in this cohort, indicating a potentially durable survival ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e18086

Safety of administration of CUE-101, a novel HPV16 E7- ... In a phase 1 trial (NCT03978689) of HLA-A*0201+ patients with relapsed HPV16+ OPSCC, CUE-101 was well tolerated, resulted in expansion of target ...

3. oncodaily.com oncodaily.com/oncolibrary/cue-101-331017

CUE-101 and Pembrolizumab Show Promising Results in ... The 12-month overall survival rate was 88%, with median overall survival reaching 32 months in this early cohort, suggesting a potentially ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11986418/

Outcomes for recurrent or metastatic head and neck cancer ... This analysis aims to assess differential outcomes specific to HPV+ and HPV− R/M HNSCC to reflect HPV-associated prognostic considerations.

5. onclive.com onclive.com/view/cue-101-plus-pembrolizumab-yields-50-orr-in-hpv-hnscc-with-low-pd-l1-expression

CUE-101 Plus Pembrolizumab Yields 50% ORR in HPV+ ... The combination therapy showed a 12-month overall survival rate of 88% and a median overall survival of 32 months. CUE-101 selectively ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04852328

Three Schedules of CUE-101 Administered Before Surgery ... This is a phase 2 trial to assess the safety and tolerability of three schedules of CUE-101 administered in the neoadjuvant phase before standard of care ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624002360

A Phase 1 Dose-escalation and Expansion Study of CUE ... Conclusion. CUE-101 demonstrates safety, tolerability and meaningful anti-cancer activity. Patients treated with CUE-101 monotherapy in 3L showed a long OS.

8. cuebiopharma.gcs-web.com cuebiopharma.gcs-web.com/news-releases/news-release-details/cue-biopharma-presents-updated-data-phase-1-trial-cue-101

Cue Biopharma Presents Updated Data from Phase 1 Trial of ... Overall response rate (ORR) of 46% and 12-month overall survival (OS) of 96% in first line (1L) recurrent/metastatic (R/M) HPV+ head and neck squamous cell ...