HLA-A02 TESTING USING ONE LAMBDAS SECORE CDX HLA SEQUENCING SYSTEM IN DAIICHI SANKYO*S FIRST-IN-HUMAN STUDY OF DS-2243a IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

HLA-A*02 TESTING USING ONE LAMBDA*S SECORE CDX HLA SEQUENCING SYSTEM IN DAIICHI SANKYO*S FIRST-IN-HUMAN STUDY OF DS-2243a IN PARTICIPANTS WITH ADVANCED SOLID TUMORS - CPSP FOR THE SECORE CDX HLA SEQUENCING SYSTEM FOR DS2243-054

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57350

Enrollment

Registered

2025-02-27

Start date

2025-01-01

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Oncology cancer tumour

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Specimens collected from patients consented by DSI*s investigator sites. Specimen collection kit contains complete and accurate paperwork. If the paperwork is not complete and/or accurate and remediation can be performed. Specimens provided by DSI investigator sites will meet collection and quality specifications per the Device IFU.

Exclusion criteria

Exclusion criteria: Specimens collected from patients not consented. Insufficient specimen quantity for testing. Specimen type not specified in this protocol. Specimen receptacle not specified in this protocol. Specimen collection kit does not contain complete and accurate paperwork to sufficiently identify the specimen, and remediation is unable to be performed. Specimens which are received in an inappropriate condition (see SeCore* CDx HLA Sequencing System, TDX-OLI-DMR-PS-3132-6).

Design outcomes

Primary

Measure	Time frame
The Device Clinical Performance Study primary endpoints is the detecting HLA-A Locus Target Alleles and distinguishing Target Alleles from other HLA-A genotypes to select participants for eligibility to receive treatment under the medicinal product clinical study. The performance of the Device for performance evaluation will be assessed based on the primary endpoints described in the medicinal product clinical study protocol (DS2243-054). A brief summary of the primary endpoints described in the medicinal product clinical study protocol is provided below: 1. Dose Escalation (Part 1): The primary endpoints of the Dose Escalation Part are dose limiting toxicity, treatment-emergent adverse event (TEAE), and other safety parameters. 2. Dose Expansion (Part 2): • Safety - The primary safety endpoints of the Dose Expansion Part are TEAEs and other safety parameters. • Efficacy - The primary efficacy endpoint of the Dose Expansion Part is overall response rate (ORR). The Device for performance evaluation will be used in this Clinical Performance Study as an aid in the determination of eligibility for enrollment in the medicinal product clinical study for patients diagnosed with advanced SS or MRCLS as well as metastatic or unresectable locally advanced NSCLC (Ad/Sq) or UC through the extraction of patient DNA from whole blood followed by PCR amplification of the target alleles and HLA-A genomic sequencing.	—

Measure

Time frame

The Device Clinical Performance Study primary endpoints is the detecting HLA-A Locus Target Alleles and distinguishing Target Alleles from other HLA-A genotypes to select participants for eligibility to receive treatment under the medicinal product clinical study. The performance of the Device for performance evaluation will be assessed based on the primary endpoints described in the medicinal product clinical study protocol (DS2243-054). A brief summary of the primary endpoints described in the medicinal product clinical study protocol is provided below: 1. Dose Escalation (Part 1): The primary endpoints of the Dose Escalation Part are dose limiting toxicity, treatment-emergent adverse event (TEAE), and other safety parameters. 2. Dose Expansion (Part 2): • Safety - The primary safety endpoints of the Dose Expansion Part are TEAEs and other safety parameters. • Efficacy - The primary efficacy endpoint of the Dose Expansion Part is overall response rate (ORR). The Device for performance evaluation will be used in this Clinical Performance Study as an aid in the determination of eligibility for enrollment in the medicinal product clinical study for patients diagnosed with advanced SS or MRCLS as well as metastatic or unresectable locally advanced NSCLC (Ad/Sq) or UC through the extraction of patient DNA from whole blood followed by PCR amplification of the target alleles and HLA-A genomic sequencing.

—

Secondary

Measure	Time frame
There are no key secondary endpoints for this clinical performance study.	—

Countries

Netherlands

Outcome results