First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer
Recruiting
Phase 1Phase 2Interventional Study
Metastatic Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 100
Sex
Male
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
42 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
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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 det…
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 Locations
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Eligibility Criteria
Inclusion 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…
Inclusion 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
* Part A Participants should have received at least 2 prior approved systemic therapies for prostate cancer with at least one androgen receptor pathway inhibitor and at least one taxane regimen if amenable
* Part B Participants should have received an androgen receptor pathway inhibitor for metastatic hormone sensitive prostate cancer or metastatic castration resistant prostate cancer (mCRPC). No prior taxane treatment for mCRPC is allowed for Module 1 and 2 Part B patients
* Adequate organ function
* Body weight ≥ 35 kg
Exclusion Criteria:
* 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
* Prior exposure to any STEAP2 targeted agents or TCEs for prostate cancer
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