Clinical performance study protocol for use of the B7-H4 (A57.1) Assay to identify and select B7-H4 positive ovarian, endometrial, biliary tract, breast cancer, and squamous non-small cell lung cancer patients for recruitment into the AstraZeneca Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Solid Tumors

Clinical Performance Study Plan for use of B7-H4 (A57.1) Assay for Patient Enrolment Into The Clinical study (D6900C00001), titled *A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Solid Tumors*. - AZD8205 in participants with metastatic solid malignancies

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53228

Enrollment

Registered

2023-09-15

Start date

2024-03-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Selected advanced solid tumors (ovarian, endometrial, biliary tract, breast, and squamous non-small cell lung cancer) expressing B7-H4 Selected advanced solid tumors (ovarian, endometrial, biliary tract, breast, and squamous non-small cell lung cancer) with B7-H4 expression

Interventions

If not present: collection of a tumor biopsy

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: FFPE tumor tissue block or slides (minimum 7) submitted for patient enrolment in accordance with standard practice. • The mandatory FFPE tumor sample should have been obtained at the time of diagnosis of metastatic or locally advanced unresectable disease (in case multiple samples are available, the most recent sample must be provided, preferentially up to 3 years old), unless this is not available, when a tumor sample from diagnosis could be provided. • Lesions used for biopsy are = 2 cm in longest diameter. It is mandated that the core biopsy be removed directly from the tumor in situ.

Exclusion criteria

Exclusion criteria: Bone biopsies, fine needle aspirates, cell pellets, ascites or pleural effusions or cytology samples.

Design outcomes

Primary

Measure	Time frame
The primary objective of this clinical performance study is to evaluate the effectiveness of the B7-H4 (A57.1) Assay in identifying B7-H4 positive (B7-H4 membrane staining at any intensity in =25% tumor cells) ovarian, endometrial, biliary tract, breast cancer and squamous NSCLC patients.	—

Countries

Australia, Belgium, Canada, China, Hungary, Italy, Japan, Netherlands, Poland, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States

Contacts

Public ContactS. Aghekian

Astra Zeneca

sylvie.aghekian@astrazeneca.com0032 (0)471 68 92 98

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026