Determination of the Claudin 6 Status Using the BioNTech Diagnostics CLAUDENTIFY® 6 IHC-Assay for the BNT142-01 study (Clinical Trial)

Determination of the Claudin 6 Status Using the BioNTech Diagnostics CLAUDENTIFY® 6 IHC-Assay for the BNT142-01 study (Clinical Trial) - CL6IHC-CPS-01 (linked to BNT142-01) ICON #4781/0029 - IVD study

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57052

Enrollment

Registered

2024-10-11

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-04-14

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

Conditions

cancer tumors

Interventions

The CLAUDENTIFY®6 IHC assay uses an immunohistochemistry (IHC) procedure for the detection of Claudin 6 protein expression in freshly collected or archived FFPE neoplastic tissue.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The CLAUDENTIFY®6 IHC-Assay will be used in this clinical performance study to qualitatively determine a patient*s Claudin 6 protein expression to identify patients who may be suitable for randomization into the BNT142-01 interventional trial to enrich for patients with a higher probability of benefit from BNT142 and excluding patients not expressing the tumor target. Complete Inclusion/Exclusion criteria for eligible participants has been defined in the Clinical Trial Protocol for BNT142-01.

Exclusion criteria

Exclusion criteria: The CLAUDENTIFY®6 IHC-Assay will be used in this clinical performance study to qualitatively determine a patient*s Claudin 6 protein expression to identify patients who may be suitable for randomization into the BNT142-01 interventional trial to enrich for patients with a higher probability of benefit from BNT142 and excluding patients not expressing the tumor target. Complete Inclusion/Exclusion criteria for eligible participants has been defined in the Clinical Trial Protocol for BNT142-01.

Design outcomes

Primary

Measure	Time frame
The objective of this specific IVDR submission is a Clinical Performance Study for the CLND6 IHC Assay, to confirm aspects of the device performance which cannot be determined by the analytical performance study. This is outlined in the CPSP on Page 6 (of 35), in the table under Objective of the Device Clinical Performance Study which states the objective is to use the CE-marked CLAUDENTIFY®6 IHC-Assay as a pre-screening test to determine Claudin 6 protein expression in patients with histological or cytological documentation of a solid tumor that is metastatic or unresectable provided as a pathology report. The outcome of the study is to determine CLDN6 expression in patients with histological or cytological documentation of a solid tumor that is metastatic or unresectable.	—

Measure

Time frame

The objective of this specific IVDR submission is a Clinical Performance Study for the CLND6 IHC Assay, to confirm aspects of the device performance which cannot be determined by the analytical performance study. This is outlined in the CPSP on Page 6 (of 35), in the table under *Objective of the Device Clinical Performance Study* which states the objective is to use the CE-marked CLAUDENTIFY®6 IHC-Assay as a pre-screening test to determine Claudin 6 protein expression in patients with histological or cytological documentation of a solid tumor that is metastatic or unresectable provided as a pathology report. The outcome of the study is to determine CLDN6 expression in patients with histological or cytological documentation of a solid tumor that is metastatic or unresectable.

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Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026