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

Recruiting

Conditions: Solid Tumor
Malignant Solid Tumor
10027655

Registration Number: NL-OMON53305

Lead Sponsor: T-knife GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 400

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

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective of this study is to further explore the percentage of<br /><br>positive tumor cells within the tumor and the overall intensity of target<br /><br>expression.<br /><br><br /><br>The secondary endpoint of this study is:<br /><br><br /><br>• Percentage of positive tumor cells within the tumor, staining intensity (+,<br /><br>++, +++) of the tumor cells, and derived histoscore for MAGE-A1 staining in the<br /><br>tumor.</p><br>