AZD8359: AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)
AZD8359: AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)
Study summary
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
Sex
MALE
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE) — From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years) 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
Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only) — From first study dose to 21 OR 28 days post first dose based on schedule 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
PSA response rate (Part B only) — Up to 3 years Number of participants with a PSA50 response
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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