XCancer

Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer

Description:

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:

AstraZeneca

Phase:

Phase 1/2

Contacts:

AstraZeneca Clinical Study Information Center (CONTACT)

information.center@astrazeneca.com

1-877-240-9479

Government Study Link:

NCT07590934 - Click here to see study on

ClinicalTrials.gov

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.