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,…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
- In-vitro diagnostic
N.a.
Outcome measures
Primary outcome
<p>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.</p>
Secondary outcome
<p>Not applicable</p>
Background summary
This clinical performance study protocol (CPSP) relates to the use of the B7-H4 (A57.1) Assay to identify and select B7-H4 positive (B7-H4 expression level at any intensity on the tumor cell surface in ≥25% tumor cells) ovarian, endometrial, biliary tract, breast 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 (D6900C00001).
Study objective
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 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 (D6900C00001).
The B7-H4 scoring data from the baseline clinical samples will be analyzed in relation to clinical outcomes to determine the predictive value of the B7-H4 biomarker for AZD8205. Statistical analysis will include, but will not be limited to: descriptive statistical analysis, logistic regression analysis, receiver operating characteristic (ROC) curve, and Youden index.
Study design
The assay was developed to test B7-H4 on tumor material from patients participating in the study: 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 (D6900C00001). If patient is found to be B7-H4 positive, he/she can participate in the study.
The study consists of 5 cohorts: biliary tract cancer, ovarian cancer, breast cancer, endometrial cancer and squamous non-small cell lung cancer.
Intervention
If not present: collection of a tumor biopsy
Study burden and risks
A new biopsy may have to be collected during screening if there is no or not enough tissue available.
S. Aghekian
Princes Beatrixlaan 582
Den Haag 2595BM
Netherlands
0032 (0)471 68 92 98
sylvie.aghekian@astrazeneca.com
S. Aghekian
Princes Beatrixlaan 582
Den Haag 2595BM
Netherlands
0032 (0)471 68 92 98
sylvie.aghekian@astrazeneca.com
Trial sites in the Netherlands
Listed location countries
Age
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
Bone biopsies, fine needle aspirates, cell pellets, ascites or pleural effusions or cytology samples.
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | 2022-502759-70 |
| CCMO | NL84167.056.23 |
| Research portal | NL-005018 |