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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
AZD8359
DrugAZD8359 Monotherapy Administration route 1
AZD8359
DrugAZD8359 Monotherapy Administration route 2
AZD8359
DrugAZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)
AZD8359
DrugAZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)
Treatment groups
42 Participants
are divided into 4 treatment groupsGroup A: Module 1 - Part A (Dose Escalation)Experimental treatment 1 intervention
Group B: Module 2 - Part A (Dose Escalation)Experimental treatment 1 intervention
Group C: Module 1/2 - Part B1 (Dose Expansion)Experimental treatment 1 intervention
Group D: Module 1/2 - Part B2 (Dose Expansion)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE)
Number of participants with AEs, AESIs, SAEs, including AEs leading to discontinuation of study intervention and clinically significant alterations from baseline in laboratory parameters, vital signs, ECGs and physical examination results
Time frame
From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years)2
Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)
A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness
Time frame
From first study dose to 21 OR 28 days post first dose based on schedule3
PSA response rate (Part B only)
Number of participants with a PSA50 response
Time frame
Up to 3 yearsSecondary outcomes
1
PSA Response rate (Part A only)
Number of participants with a PSA50 response
Time frame
Up to 3 years2
PSA Response rate
Number of participants with a PSA90 response
Time frame
Up to 3 years3
Time to PSA response
Time taken to achieve a PSA response
Time frame
Up to 3 years4
Duration of PSA response
Time PSA response lasts
Time frame
Up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov