Exploring HLA-A*02:01 and NY-ESO-1 in Cancer Patients in Taiwan

A Prospective Observational Human Subject Research to Explore the HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan

This study is trying to see how common certain markers are in cancer patients in Taiwan to help find new treatment options.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: PharmaEssentia (Industry-sponsored)
• Locations: 6 sites (Chiayi City, Taiwan and 5 other locations)
• Trial ID: NCT06665776 on ClinicalTrials.gov

What this trial studies

This observational research aims to investigate the frequency of the HLA-A*02:01 allele and the expression of NY-ESO-1 in cancer patients within the Taiwanese population. It will enroll patients diagnosed with various solid tumors, including triple-negative breast cancer and hepatocellular carcinoma, to assess the prevalence of these markers. High-resolution genotyping and immunohistochemistry will be utilized to evaluate HLA-A*02:01 and NY-ESO-1 expression. The findings could provide insights into potential therapeutic strategies involving T cell receptor-engineered T cells targeting NY-ESO-1.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with specific solid tumors such as triple-negative breast cancer or hepatocellular carcinoma.

Not a fit: Patients with solid tumors not included in the eligibility criteria or those who do not express HLA-A*02:01 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of patient eligibility for targeted T cell therapies in solid tumors.

How similar studies have performed: While studies on HLA-A*02:01 and NY-ESO-1 have shown promise, this specific investigation into the Taiwanese population is novel.

Eligibility criteria

Inclusion Criteria:

1. Able to understand and voluntarily sign an informed consent form (ICF).
2. Adult aged ≥ 18 years at the time of informed consent (or other age required by local regulations).
3. Confirmed diagnosis of any of the following solid tumor:

   1. Head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma;
   2. Hepatocellular carcinoma;
   3. Lung squamous cell carcinoma;
   4. Synovial sarcoma;
   5. Triple-negative breast cancer;
   6. Esophageal squamous cell carcinoma;
   7. Cervical cancer;
   8. Ovarian cancer
4. Patient who received standard curative or palliative therapy including but not limited to any targeted therapy based on mutation status for their cancer, or patient with advanced solid tumors for which there is no accepted therapy, standard therapies are no longer effective, or the patient refuses additional standard therapy.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
6. Body weight ≥ 50 Kg.
7. Life expectancy of ≥ 6 months.
8. Patient who agrees to provide the tumor sample for NY-ESO-1 IHC staining, from either fresh or archival tissue

Exclusion Criteria:

1. Known primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or AIDS).
2. Uncontrolled intercurrent illness which is not suitable for enrollment at the discretion of the investigator, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements.
3. Currently confirmed diagnosis of at least 2 active cancers; patient who was cured of the other cancer \[disease free period \> 6 months\] and currently has only one research targeted tumor can be enrolled.
4. Untreated or symptomatic brain metastasis.
5. History of organ transplantation or allogeneic stem cell transplantation.
6. Other conditions (e.g. previous use of any cell therapy) which are not suitable for enrollment at the discretion of the investigator.

Where this trial is running

Chiayi City, Taiwan and 5 other locations

• Chang Gung Memorial Hospital, Chiayi Branch — Chiayi City, Taiwan, Taiwan (Recruiting)
• Taichung Veterans General Hospital — Taichung, Taiwan, Taiwan (Recruiting)
• National Cheng Kung University Hospital — Tainan, Taiwan, Taiwan (Recruiting)
• Taipei Veterans General Hospital — Taipei, Taiwan, Taiwan (Recruiting)
• National Taiwan University Hospital — Taipei, Taiwan, Taiwan (Recruiting)
• Taipei Medical University Hospital — Taipei, Taiwan, Taiwan (Recruiting)

Study contacts

• Study coordinator: Hsi-Chi Chang

Conditions Solid Tumor Malignancy; NY-ESO-1; HLA-A*02:01; Solid tumor