First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer

This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD8359. The study is split into different modules which will look at AZD8359 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels and dosing schedules of AZD8359 to determine which doses are the best in terms of safety and side effects (dose escalation), and Part B will further test at least two AZD8359 doses in a larger group of participants (dose expansion).

Trial Details

NCT ID
NCT07529717
Phase
PHASE1 / PHASE2
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • AZD8359
Locations (sample)
  • Orlando, Florida, United States|28.53834,-81.37924
  • East Brunswick, New Jersey, United States|40.42788,-74.41598
  • Hackensack, New Jersey, United States|40.88593,-74.04347
  • Providence, Rhode Island, United States|41.82399,-71.41283
  • Darlinghurst, Australia|-33.87939,151.21925

Key Eligibility Criteria

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer
  • Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L)
  • PSA value at screening should be ≥ 1ng/mL
  • Evidence of disease progression within 6 months prior to screening

For full eligibility, visit ClinicalTrials.gov.

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