First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AZD8359, AZD8359, AZD8359, AZD8359.
- Who it may be relevant to
- Registry conditions: Metastatic Prostate Cancer. Basic parameters: 18 years — 100 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase I/II Dose Escalation & Dose Optimization Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD8359, a CD8-guided T Cell-engaging Antibody That Targets STEAP2, in Adult Participants With Prostate Cancer
Overview
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).
Detailed description
This is a first-in-human, modular, Phase I/II, open label, multicenter study of AZD8359, in adult participants with metastatic prostate cancer. The study will consist of study modules, each evaluating the the safety, tolerability, preliminary efficacy, immune cell activation and anti-tumor activity of AZD8359. The study will also characterize the pharmacokinetics and immunogenicity of AZD8359.
Interventions
- Drug AZD8359
AZD8359 Monotherapy Administration route 1 - Drug AZD8359
AZD8359 Monotherapy Administration route 2 - Drug AZD8359
AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1) - Drug AZD8359
AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)
Primary outcome measures
- Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE) [Time frame: From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years)]
- Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only) [Time frame: From first study dose to 21 OR 28 days post first dose based on schedule]
- PSA response rate (Part B only) [Time frame: Up to 3 years]
Secondary outcome measures (12)
- PSA Response rate (Part A only) [Time frame: Up to 3 years]
- PSA Response rate [Time frame: Up to 3 years]
- Time to PSA response [Time frame: Up to 3 years]
- Duration of PSA response [Time frame: Up to 3 years]
- Durable PSA response rate [Time frame: Up to 3 years]
- Time to PSA progression [Time frame: Up to 3 years]
- Objective Response Rate (ORR) [Time frame: Up to 3 years]
- Duration of Response (DoR) [Time frame: Up to 3 years]
- Disease Control Rate (DCR) [Time frame: 16 Weeks]
- Time To Response (TTR) [Time frame: Up to 3 years]
- Radiographic Progression Free Survival (rPFS) [Time frame: Up to 3 years]
- Durable Response Rate (DRR) [Time frame: Up to 3 years]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Research Site — Orlando
- Research Site — East Brunswick
- Research Site — Hackensack
- Research Site — Providence
Australia · 2 centers
- Research Site — Darlinghurst
- Research Site — Melbourne
South Korea · 2 centers
- Research Site — Seoul
- Research Site — Seoul
Identifiers
NCT: NCT07529717 · D8040C00001