HB-202/HB-201 for Head and Neck Cancer

Recruiting at 6 trial locations

Overseen By Alan Ho, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Systemic corticosteroids, Antivirals, Immunosuppressants, others

Disqualifiers: Recurrent cancer, Autoimmune disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

10 Participants Needed

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use systemic corticosteroids within 4 weeks of registration, and herbal remedies with immune-stimulating properties are not allowed within 28 days before the first dose. If you're on chronic antiviral medication, you cannot participate. It's best to discuss your specific medications with the trial team.

What data supports the idea that HB-202/HB-201 for Head and Neck Cancer is an effective treatment?

The available research shows that HB-202/HB-201, which targets HPV-16, is promising for treating head and neck cancer. Studies indicate that HPV-16 is a major factor in these cancers, especially in the oropharynx. The treatment aims to boost the body's immune response to fight the cancer cells. While specific data on HB-202/HB-201's effectiveness isn't detailed, similar HPV vaccines have shown potential in animal and early human trials. This suggests that enhancing the immune system can help clear HPV infections, which is a hopeful sign for this treatment's success. ^{1 2 3 4 5}

What safety data exists for the HB-202/HB-201 treatment for head and neck cancer?

The provided research does not directly address the safety data for HB-202/HB-201 or its related names. The studies focus on HPV-associated head and neck cancers, the role of HPV-16 in these cancers, and the development of vaccines targeting HPV antigens. However, they do not provide specific safety data for the HB-202/HB-201 treatment. Further investigation into clinical trial results or specific studies on HB-202/HB-201 would be necessary to obtain safety data. ^{1 3 4 6 7}

Is the treatment HB-202/HB-201 promising for head and neck cancer?

Yes, the treatment HB-202/HB-201 is promising for head and neck cancer because it targets HPV-16, a common cause of these cancers. It uses the body's immune system to fight cancer cells by focusing on specific proteins that are important for the cancer's growth. This approach has shown potential in improving outcomes for patients with HPV-related head and neck cancers. ^{1 3 4 8 9}

What is the purpose of this trial?

The researchers are doing this study to find out if HB-202/HB-201 is a feasible treatment for people with HPV 16-positive head and neck squamous cell cancer (HPV 16+ HNSCC) who have received standard treatment for their disease but then tested positive for HPV 16-related tumor DNA in the blood through a test called NavDx. Participants will have no evidence of cancer on imaging scans (radiographically) or by medical examination (clinically). Past studies have shown that a positive NavDx test strongly suggests the possible presence of microscopic cancer, though we do not know if testing positive will definitely lead to the cancer coming back (recurrence). The NavDx blood test has not been approved by the FDA and is considered investigational.

Research Team

Winston Wong, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for individuals with HPV 16-positive head and neck cancer who've completed standard treatment but have signs of potential microscopic cancer as indicated by a positive NavDx blood test. They should show no visible signs of cancer on scans or physical exams.

Inclusion Criteria

My kidney function is normal as of my last test.

Subject must provide voluntary study-specific informed consent prior to study entry

Adequate hematologic function within 30 days prior to registration

Exclusion Criteria

Severe, active co-morbidity

I have not received any live vaccines in the last 28 days.

I am on long-term antiviral medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HB-202 and HB-201 in an alternating fashion or placebo for a full one-year duration

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 3 years

Treatment Details

Interventions

• HB-202/HB-201

Trial Overview The study tests HB-202/HB-201 to see if it's effective in treating HPV 16+ HNSCC after standard treatments, using the investigational NavDx test to detect possible remaining cancer at the microscopic level.

Participant Groups

Group I: HB-200 arm Experimental Treatment 1 Intervention

HB-202 and HB-201 will be given in an alternating fashion for 4 total treatments.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Naveris

Collaborator

Trials

3

Recruited

260+

Hookipa Biotech GmbH

Industry Sponsor

Trials

9

Recruited

1,100+

Findings from Research

In patients with HPV-16+ squamous cell carcinoma of the head and neck (SCCHN), T-cell responses against HPV-16 E7 peptides were significantly higher compared to HPV-16- patients and healthy volunteers, indicating a strong immune response linked to HPV infection.

The study suggests that HPV-16+ tumors exhibit immune escape mechanisms due to down-regulation of critical components for antigen processing, which could be targeted to enhance the effectiveness of E7-specific immunotherapy in treating HPV-associated SCCHN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor activity of human papillomavirus type 16 E7-specific T cells against virally infected squamous cell carcinoma of the head and neck. Albers, A., Abe, K., Hunt, J., et al.[2021]

Human papillomavirus (HPV) is linked to a significant portion of head and neck cancers, particularly oropharyngeal carcinomas, highlighting the need for effective therapeutic strategies against HPV-related tumors.

Current research is focused on developing immunotherapy and therapeutic vaccines for HPV, with promising evidence suggesting that enhancing immune responses could effectively clear HPV infections and improve treatment outcomes for head and neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus therapeutic vaccines in head and neck tumors. Badaracco, G., Venuti, A.[2007]

The CRT/E7(N53S) DNA vaccine effectively generated specific CD8+ T cell responses against HPV16 E7 in HLA-A2 transgenic mice, demonstrating its potential as a therapeutic option for HPV-associated head and neck cancers.

Treatment with the CRT/E7(N53S) DNA vaccine resulted in significant antitumor effects against spontaneous oral tumors induced by HPV16 E6/E7, indicating its efficacy in controlling HPV-related malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of Spontaneous HPV16 E6/E7 Expressing Oral Cancer in HLA-A2 (AAD) Transgenic Mice with Therapeutic HPV DNA Vaccine. Tseng, SH., Liu, L., Peng, S., et al.[2022]

HPV-positive tumors account for a significant portion of oropharyngeal squamous cell carcinomas (OSCC), with HPV-16 being the most common high-risk genotype, highlighting the importance of HPV in the development of these cancers.

Current treatment strategies for HPV-induced head and neck squamous cell carcinomas are shifting towards de-escalation, and new immunotherapy approaches are being explored to enhance the immune response against these tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated overview of HPV-associated head and neck carcinomas. Zaravinos, A.[2022]

In a study of 109 newly diagnosed head and neck cancer (HNC) patients, higher levels of antibodies to HPV-16 E6 and E7 were linked to increased risk factors such as younger age, more sexual partners, and worse cancer stages, indicating a potential role of these antibodies in assessing HNC risk.

Patients who were seropositive for HPV-16 E6 had significantly better overall survival rates compared to seronegative patients, suggesting that these antibodies could serve as important prognostic markers for survival in HNC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus serologic follow-up response and relationship to survival in head and neck cancer: a case-comparison study. Rubenstein, LM., Smith, EM., Pawlita, M., et al.[2021]

The ongoing clinical trial (NCT04199689) is evaluating the efficacy of the 9-valent HPV vaccine in preventing oral persistent infections caused by high-risk HPV types in 6000 men aged 20-45, aiming to reduce the incidence of HPV-related head and neck cancers.

The study will assess both the primary endpoint of HPV-related oral infections and secondary endpoints related to other HPV types, while also monitoring safety through adverse event reporting for 15 days post-vaccination and serious events for 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a phase III efficacy, immunogenicity, and safety study of 9-valent human papillomavirus vaccine in prevention of oral persistent infection in men. Giuliano, AR., Wilkin, T., Bautista, OM., et al.[2022]

The MK16/1/IIIABC cell line, created by transforming mouse kidney cells with HPV16 and activated H-ras oncogenes, serves as a promising model for studying immune responses to HPV16-related cancers, as it shows spontaneous metastasis in lymph nodes and lungs.

Immunization with plasmids carrying HPV16 oncogenes provided moderate protection against tumor challenges in mice, indicating potential for developing preventive strategies against HPV-associated tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic MHC class I-negative mouse cells derived by transformation with human papillomavirus type 16. Smahel, M., Sobotková, E., Bubeník, J., et al.[2018]

In a study of 301 head and neck cancer patients, the presence of the p16 biomarker was significantly associated with high-risk HPV types, indicating that p16+ tumors have better clinical outcomes compared to p16- tumors.

When analyzing survival outcomes, patients with both p16+ and HPV-HR had the best disease-specific survival, while those with p16- and HPV- had the worst, suggesting that evaluating both biomarkers together provides a more accurate prediction of prognosis than examining them individually.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

P16INK4a expression, human papillomavirus, and survival in head and neck cancer. Smith, EM., Wang, D., Kim, Y., et al.[2015]

In a study of 382 head and neck squamous cell carcinoma (HNSCC) patients, antibody responses to nonviral cancer antigens were found to differ significantly between HPV-positive and HPV-negative cases, indicating distinct antigen expression patterns.

The research utilized a multiplex serology approach to analyze responses to 29 cancer antigens, revealing that 72% of patients had detectable antibody responses, which could potentially be used for noninvasive liquid biopsies to assess tumor antigen expression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of antibody responses to nonviral cancer antigens in head and neck squamous cell carcinoma patients differ by human papillomavirus status. Gangkofner, DS., Holzinger, D., Schroeder, L., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Antitumor activity of human papillomavirus type 16 E7-specific T cells against virally infected squamous cell carcinoma of the head and neck. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Human papillomavirus therapeutic vaccines in head and neck tumors. [2007]

3. England pubmed.ncbi.nlm.nih.gov

Control of Spontaneous HPV16 E6/E7 Expressing Oral Cancer in HLA-A2 (AAD) Transgenic Mice with Therapeutic HPV DNA Vaccine. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

An updated overview of HPV-associated head and neck carcinomas. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Human papillomavirus serologic follow-up response and relationship to survival in head and neck cancer: a case-comparison study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Design of a phase III efficacy, immunogenicity, and safety study of 9-valent human papillomavirus vaccine in prevention of oral persistent infection in men. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Metastatic MHC class I-negative mouse cells derived by transformation with human papillomavirus type 16. [2018]

8. England pubmed.ncbi.nlm.nih.gov

P16INK4a expression, human papillomavirus, and survival in head and neck cancer. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Patterns of antibody responses to nonviral cancer antigens in head and neck squamous cell carcinoma patients differ by human papillomavirus status. [2020]