First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer
ConditionMetastatic Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18-100
SponsorAstraZeneca
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
Any clinically relevant cardiac abnormalities such as QT prolongation or uncontrolled cardiac arrythmias
All prior treatment-related adverse events must have resolved to Grade ≤ 2
History of Grade ≥ 3 cytokine release syndrome or Grade ≥ 2 immune effector cell-associated neurotoxicity syndrome with prior therapy
Active or prior documented autoimmune or inflammatory disorders within the past 3 years
Trial design
Treatments tested in this trial
- AZD8359
- AZD8359
- AZD8359
- AZD8359
Treatment groups
42 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov