42 Participants NeededMy employer runs this trial

AZD8359 for Prostate Cancer

(CRIUS-1 Trial)

Recruiting at 6 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: AstraZeneca
Must be taking: Androgen inhibitors, Taxanes
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called AZD8359 for individuals with advanced prostate cancer that has spread to other parts of the body. Researchers aim to assess the safety and effectiveness of this treatment by testing different doses to identify the optimal one. The study consists of two parts: one part determines the right dose, and the other tests these doses in a larger group. This trial may suit those whose prostate cancer worsens despite treatment and who have already tried certain cancer medications. As a Phase 1 and Phase 2 trial, participants will be among the first to receive this new treatment and help determine its effectiveness in a smaller group.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AZD8359 is likely to be safe for humans?

An earlier study tested AZD8359 in people with advanced prostate cancer to assess its safety. Researchers found that AZD8359 is generally safe, meaning most patients tolerated it well. The study aimed to determine the optimal dose, so participants received varying amounts to identify which worked best with the fewest side effects. While specific side effects are not detailed in the sources, the progression of this treatment to later testing stages suggests it has demonstrated promising safety results.12345

Why are researchers excited about this trial's treatment for prostate cancer?

Unlike the standard treatments for prostate cancer, which often include hormone therapy, chemotherapy, or radiation, AZD8359 is unique because it targets a specific mechanism in cancer cells that current options don't address. AZD8359 works by inhibiting a novel pathway that is crucial for the survival and growth of prostate cancer cells, potentially leading to more effective outcomes. Researchers are excited about AZD8359 because it offers a new way to attack cancer cells, potentially overcoming resistance seen with traditional therapies and improving treatment responses.

What evidence suggests that AZD8359 might be an effective treatment for metastatic prostate cancer?

Studies have shown that AZD8359, a new treatment for advanced prostate cancer, shows promise in fighting tumors. Early research demonstrated that AZD8359 helped the body's immune cells, known as T cells, attack prostate cancer cells, enhancing the body's natural defenses against cancer. Tests in mice suggested that AZD8359 might be safer and more effective than some current treatments. This trial will explore different dosing strategies of AZD8359, including dose escalation and expansion phases, to further evaluate its safety and effectiveness in humans. Although more research in humans is needed, these early results offer hope for its potential use in treating prostate cancer.12346

Are You a Good Fit for This Trial?

This trial is for adults with advanced prostate cancer that has spread and is getting worse. Participants must have a confirmed diagnosis, certain PSA levels, good organ function, and low testosterone. They should have tried specific previous treatments but not some others. People with serious heart issues or recent autoimmune diseases cannot join.

Inclusion Criteria

PSA value at screening should be ≥ 1ng/mL
Body weight ≥ 35 kg
I have been diagnosed with prostate adenocarcinoma or neuroendocrine prostate cancer.
See 5 more

Exclusion Criteria

I do not have serious heart rhythm problems or abnormal heartbeats.
Any side effects from my past treatments are mild or moderate now.
Active or prior documented autoimmune or inflammatory disorders within the past 3 years
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part A)

Participants receive different dose levels and dosing schedules of AZD8359 to determine the best doses in terms of safety and side effects

Up to 3 years
Regular visits as per dosing schedule

Dose Expansion (Part B)

Further testing of at least two AZD8359 doses in a larger group of participants

Up to 3 years
Regular visits as per dosing schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • AZD8359

Trial Overview

The study tests AZD8359, an experimental drug targeting STEAP2 in prostate cancer. It will be given in different ways and doses to find the safest amount and best schedule (Part A), then tested further at selected doses in more people (Part B).

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Module 2 - Part A (Dose Escalation)Experimental Treatment1 Intervention
Group II: Module 1/2 - Part B2 (Dose Expansion)Experimental Treatment1 Intervention
Group III: Module 1/2 - Part B1 (Dose Expansion)Experimental Treatment1 Intervention
Group IV: Module 1 - Part A (Dose Escalation)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

First-in-Human Study to Evaluate AZD8359 STEAP2 TCE ...

This is a first-in-human, modular, Phase I/II, open label, multicenter study of AZD8359, in adult participants with metastatic prostate cancer.

First-in-Human Study to Evaluate AZD8359 STEAP2 TCE ...

This is a first-in-human, modular, Phase I/II, open label, multicenter study of AZD8359, in adult participants with metastatic prostate cancer.

AZD8359 for Prostate Cancer (CRIUS-1 Trial)

This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic ...

AZD8359: Uses, Side Effects, Dosing & 1 Clinical Trials

The trial's objective is to assess the safety profile of AZD8359 and to gather preliminary data on its efficacy in treating metastatic prostate ...

AZD8359 Shows Promising Antitumor Activity in Prostate ...

AZD8359 - A novel CD8‑biased T cell engager designed to deliver a wider therapeutic window in prostate cancer In immune-humanized mice, ...

AZD8359 / AstraZeneca

... AZD8359 confers a wider preclinical therapeutic index compared to conventional TCEs in prostate cancer. This preclinical package underpins the clinical ...