Assessing Frequency of HLA-Genotype and Tumor Antigen Expression in Subjects with Relapsed/Refractory, Advanced-Stage Solid Tumors that may Qualify for Novel T Cell Receptor Based Therapies

Assessing Frequency of HLA-Genotype and Tumor Antigen Expression in Subjects with Relapsed/Refractory, Advanced-Stage Solid Tumors that may Qualify for Novel T Cell Receptor Based Therapies - Assessing Frequency of HLA-Genotype for TCR Based Therapies

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53305

Enrollment

400

Registered

2023-07-06

Start date

2023-09-07

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Signed written informed consent. 2. Histologically or cytologically confirmed diagnosis of relapsed/refractory, advanced stage solid tumor that may express MAGE-A1. 3. Subject received at least one line of approved systemic therapy and is declared to be in a non-curable disease state as per treating physician*s current assessment. 4. Availability of a stored, accessible tumor sample for IHC. 5. Ability to provide a blood sample. 6. Age >= 18 years. 7. Life expectancy > 6 months as per treating physician*s assessment.

Exclusion criteria

Exclusion criteria: 1. Any bleeding or coagulation disorder or other condition that would present the subject with an undue risk when undergoing a venous blood draw. 2. Any other condition that could interfere with subject's safety, obtaining informed consent, or compliance to the screening study procedures. 3. Presence of any organ toxicities or other conditions that would preclude intense future anticancer treatments such as required for T cell receptor therapy.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to assess the frequency of HLA-A02:01 genotype and tumoral expression of MAGE-A1 in subjects with relapsed/refractory, advanced-stage solid tumors that may express MAGE-A1, are in advanced, non-curable state, and have received at least one line of systemic therapy for their disease. The primary endpoints of this study are: • Frequency of HLA-A02:01 genotype • Frequency of immunohistochemically MAGE-A1 positive tumors in subjects with HLAA*02:01 genotype	—

Measure

Time frame

The primary objective of this study is to assess the frequency of HLA-A*02:01 genotype and tumoral expression of MAGE-A1 in subjects with relapsed/refractory, advanced-stage solid tumors that may express MAGE-A1, are in advanced, non-curable state, and have received at least one line of systemic therapy for their disease. The primary endpoints of this study are: • Frequency of HLA-A*02:01 genotype • Frequency of immunohistochemically MAGE-A1 positive tumors in subjects with HLAA*02:01 genotype

—

Secondary

Measure	Time frame
The secondary objective of this study is to further explore the percentage of positive tumor cells within the tumor and the overall intensity of target expression. The secondary endpoint of this study is: • Percentage of positive tumor cells within the tumor, staining intensity (+, ++, +++) of the tumor cells, and derived histoscore for MAGE-A1 staining in the tumor.	—

Countries

Netherlands

Outcome results