The primary objective of this clinical performance study is to evaluate the effectiveness of the B7-H4 (A57.1) CTA 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
Outcome measures
Primary outcome
The primary objective of this clinical performance study is to evaluate the
effectiveness of the B7-H4 (A57.1) CTA in identifying B7-H4 positive (B7-H4
membrane staining at any intensity in >=25% tumor cells) ovarian, endometrial,
biliary tract and breast cancer
Secondary outcome
Not applicable
Background summary
This clinical performance study protocol (CPSP) relates to the use of the B7-H4
(A57.1) Clinical Trial Assay (CTA) 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 and breast cancer patients for
recruitment into the AstraZeneca Phase I/IIa Multi-center, Open-label Master
Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics,
Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants
with Advanced or Metastatic Solid Malignancies (D6900C00001).
Study objective
The primary objective of this clinical performance study is to evaluate the
effectiveness of the B7-H4 (A57.1) CTA in identifying B7-H4 positive (B7-H4
membrane staining at any intensity in >=25% tumor cells) ovarian, endometrial,
biliary tract and breast cancer patients for recruitment into the AstraZeneca
Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety,
Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor
Activity of AZD8205 in Participants with Advanced or Metastatic Solid
Malignancies (D6900C00001) study.
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 to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics
and preliminary antitumor activity of AZD8205 in participants with Advanced or
metastatic solid malignancies (D6900C00001). If patient has >50% expression of
B7-H4 he/she can participate in the study.
The study consists of 4 cohorts: biliary tract cancer, ovarian cancer, breast
cancer and endometrial 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
Prinses Beatrixlaan 582
Den Haag 2595BM
NL
Prinses Beatrixlaan 582
Den Haag 2595BM
NL
Listed location countries
Age
Inclusion criteria
Eastern Cooperative Oncology Group PS 0-1.
Participants with relapsed/metastatic solid tumors (biliary tract cancer,
ovarium cancer, breast cancer or endometrial cancer) must have received prior
adequate SoC therapy for their tumor type and stage of disease
Participants must have measurable disease per RECIST v1.1
Life expectancy >= 12 weeks
Adequate organ function
The respective cohorts for patient inclusion are:
- Cohort 1: Biliary tract cancer
- Cohort 2: Ovarian cancer
- Cohort 3: Breast cancer
- Cohort 4: Endometrial cancer
Exclusion criteria
Participants with spinal cord compression or a history of leptomeningeal
carcinomatosis
Participants with brain metastases unless treated, asymptomatic, stable
Unresolved toxicities of Grade >= 2 (NCI CTCAE v5.0) from prior therapy
Active infection, including tuberculosis and infections with HBV, HCV or HIV
Has a history of (non-infectious) ILD/pneumonitis that required steroids, has
current
ILD/pneumonitis
Clinically severe pulmonary compromise resulting from intercurrent pulmonary
illnesses
History of another primary malignancy
Participants with History of arrhythmia, Uncontrolled hypertension, Acute
coronary syndrome/acute myocardial infarction, unstable angina pectoris and
other heart diseases
Uncontrolled intercurrent illness
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| Other | EU CT number: 2022-502759-70-00 |
| CCMO | NL84167.056.23 |