AZD9750 for Prostate Cancer

(ANDROMEDA Trial)

Not yet recruiting at 8 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
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?

ANDROMEDA is a first-in-human, Phase I/II, open-label, multicenter study of AZD9750 in participants with metastatic prostate cancer. The trial evaluates safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AZD9750 as monotherapy and in combination with saruparib.

Are You a Good Fit for This Trial?

This trial is for adults with metastatic prostate cancer who have seen their disease progress. They must have a confirmed diagnosis, low testosterone levels, and show signs of the cancer worsening on scans or through rising PSA levels. Participants need to be in good physical condition with proper organ and bone marrow function.

Inclusion Criteria

My cancer has spread to my bones, showing at least 2 new lesions.
I am at least 18 years old or the legal age in my country.
My prostate cancer diagnosis was confirmed through tissue analysis.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive AZD9750 as monotherapy or in combination with saruparib, with treatment continuing until disease progression, unacceptable toxicity, or withdrawal of consent

Variable, up to 60 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

37 days after the last dose of study treatment

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • AZD9750

Trial Overview

The ANDROMEDA study is testing AZD9750 alone and combined with saruparib in people with advanced prostate cancer. It's an early-stage trial to check how safe these drugs are, how the body processes them, and if they're effective at treating the cancer.

How Is the Trial Designed?

7

Treatment groups

Experimental Treatment

Group I: Module 2/ Part BExperimental Treatment2 Interventions
Group II: Module 2 / Part AExperimental Treatment2 Interventions
Group III: Module 1 Part B2Experimental Treatment1 Intervention
Group IV: Module 1 / Part B3Experimental Treatment1 Intervention
Group V: Module 1 / Part B1Experimental Treatment1 Intervention
Group VI: Module 1 / Part A2Experimental Treatment1 Intervention
Group VII: Module 1 / Part A1Experimental 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