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RecruitingPhase 1 / Phase 2

First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests AZD8359, an experimental treatment for prostate cancer that has spread to other parts of the body. It looks at safety, side effects, and how well the treatment works. Researchers will test different ways to give it, doses, and dose schedules.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test must show prostate adenocarcinoma or prostate cancer with neuroendocrine features.
  • You must have had surgery or medicine to lower testosterone, with a blood level of 50 ng/dL or less.
  • Your PSA level, a blood marker for prostate cancer, must be at least 1 ng/mL at screening.
  • Your cancer must have gotten worse within the 6 months before screening.
  • Part A: You must have had at least 2 approved drug treatments for prostate cancer, including a drug that blocks male hormone signals and taxane chemotherapy if suitable.
  • Part B: You must have had a drug that blocks male hormone signals for prostate cancer that has spread. In Modules 1 and 2, you cannot have had taxane chemotherapy for cancer that keeps growing despite treatment to lower testosterone.
  • Your organs must work well enough for the study.
  • You must weigh at least 35 kg (about 77 pounds).

Who can't join

  • You have important heart problems, such as certain changes in the heart's electrical signals or an uncontrolled uneven heartbeat.
  • Side effects from past treatment have not improved to grade 2 (moderate) or less.
  • Past treatment caused grade 3 or worse cytokine release syndrome (a severe immune reaction), or grade 2 or worse immune-related problems affecting the brain or nerves.
  • You have had a documented autoimmune disease (when the immune system attacks the body) or inflammatory disorder within the past 3 years.
  • You have had prostate cancer treatment that targets STEAP2 or uses a T-cell engager (TCE), which helps immune cells attack cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (4)

FL

NJ

RI