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

Study Identifier:
D8040C00001
CT.gov Identifier:
NCT07529717
EudraCT Identifier:
202552475833
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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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).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Prostate
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I/II
Sex
Male
Age
18 - 100 Years
Study Drug
Drug: EXPERIMENTAL: Module 1/2 - Part B1 (Dose Expansion)
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Drug: Drug: AZD8359
Drug: AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)
Drug: EXPERIMENTAL: Module 1/2 - Part B2 (Dose Expansion)
Drug: AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)
Drug: EXPERIMENTAL: Module 1 - Part A (Dose Escalation)
Drug: AZD8359 Monotherapy Administration route 1
Drug: EXPERIMENTAL: Module 2 - Part A (Dose Escalation)
Drug: AZD8359 Monotherapy Administration route 2
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Neel Belani
Bruno Fang
Status
Will Be Recruiting
Condition(s) Treated at Site
Prostate