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Clinical Trial · NCT07590934
Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer
Overview
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of multiple anti-cancer agents in participants with metastatic prostate cancer.
Sponsor
AstraZenecaPhase
Phase 1/2
Contacts
AstraZeneca Clinical Study Information Center (CONTACT)
information.center@astrazeneca.com
1-877-240-9479
ClinicalTrials.gov
NCT07590934Eligibility
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration.
- PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease.
- Minimum life expectancy of 3 months or more.
- Must have received at least one novel androgen receptor pathway inhibitor (ARPI), such as enzalutamide or darolutamide or apalutamide or abiraterone acetate.
- 1. Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell).
Exclusion
- 1. Any evidence of non adenocarcinomatous forms of prostate cancer (including small cell, spindle cell, signet cell, neuroendocrine, sarcomatous).
- Participants with a history of leptomeningeal carcinomatosis.
- Symptomatic malignant spinal cord compression or findings indicative of impending cord compression.
- Participants with a history of central nervous system metastases.
- Known, unresolved urinary tract obstruction.
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