AZD8359 for Prostate Cancer

(CRIUS-1 Trial)

Not yet recruiting at 6 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must be taking: Androgen inhibitors, Taxanes

Disqualifiers: Cardiac abnormalities, Autoimmune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

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.

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

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

How Is the Trial Designed?

Group I: Module 2 - Part A (Dose Escalation) Experimental Treatment 1 Intervention

Group II: Module 1/2 - Part B2 (Dose Expansion) Experimental Treatment 1 Intervention

Group III: Module 1/2 - Part B1 (Dose Expansion) Experimental Treatment 1 Intervention

Group IV: Module 1 - Part A (Dose Escalation) Experimental Treatment 1 Intervention

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