Clinical Performance Study Plan for use of B7-H4 (A57.1) Clinical Trial Assay for Patient Enrolment Into The Clinical study (D6900C00001), titled *A 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*.

Not yet recruiting

• Conditions: metastatic solid tumors; Selected metastatic solid tumors expressing B7-H4; 10027476

• Registration Number: NL-OMON53228
• Lead Sponsor: Astra Zeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified