AZD9750 for Prostate Cancer

(ANDROMEDA Trial)

Not yet recruiting at 8 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must not be taking: AR-PROTAC

Disqualifiers: Small cell carcinoma, Brain metastases, Cardiac disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Variable, up to 60 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called AZD9750 for individuals with metastatic prostate cancer that has spread. Researchers aim to assess the safety and effectiveness of AZD9750 both alone and in combination with another drug, saruparib. The study seeks participants diagnosed with prostate cancer that has progressed despite low testosterone levels and previous treatments like hormone therapy or chemotherapy. Those with prostate cancer that has spread and who have noticed worsening symptoms or rising PSA levels might be suitable candidates. As a Phase 1, Phase 2 trial, this study focuses on understanding how AZD9750 works in people and measuring its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking research.

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 this trial's treatments are likely to be safe?

Research has shown that AZD9750, a new treatment for prostate cancer, may help reduce or even shrink tumors, suggesting potential effectiveness. However, detailed safety information for humans remains limited as the treatment is still in early trials. These trials are crucial for understanding human responses to the drug.

When combined with another drug, saruparib, some early information about saruparib's safety is available. Studies have indicated that saruparib, when used with other treatments, can cause tiredness, nausea, or low blood counts. These side effects are common in many cancer treatments and are usually manageable by doctors.

Since AZD9750 and its combination with saruparib are in the early stages of testing (Phase 1/2), researchers are closely monitoring their safety. This phase involves finding the right dose and checking for any serious side effects. Participating in such a trial contributes to important research to ensure the treatment is safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AZD9750 for prostate cancer because it represents a novel approach compared to traditional treatments like hormone therapy, chemotherapy, or surgery. AZD9750 offers a unique mechanism of action, potentially targeting cancer cells in a way that current therapies do not. Furthermore, in some trial arms, AZD9750 is being combined with Saruparib, which could enhance its effectiveness by tackling the cancer through multiple pathways. This combination approach might offer improved outcomes for patients who have not responded well to existing treatments.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research shows that AZD9750 may help treat prostate cancer by targeting a specific pathway that aids cancer growth. In earlier studies, AZD9750 not only slowed tumor growth but also shrank tumors in some cases. Tests on animals demonstrated that AZD9750 significantly slowed tumor growth. In this trial, some participants will receive AZD9750 alone, while others will receive a combination of AZD9750 and saruparib. Early results suggest that the combination works well for patients with advanced prostate cancer. These findings offer hope for those considering this treatment option. ^{2 3 4 6 7}

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.

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?

Group I: Module 2/ Part B Experimental Treatment 2 Interventions

AZD9750 + Saruparib (Combination Dose Expansion) - No Randomization

Group II: Module 2 / Part A Experimental Treatment 2 Interventions

AZD9750 + Saruparib (Combination Dose Finding) - No Randomization

Group III: Module 1 Part B2 Experimental Treatment 1 Intervention

AZD9750 Monotherapy (Dose Expansion) - No randomization

Group IV: Module 1 / Part B3 Experimental Treatment 1 Intervention

AZD9750 Monotherapy (Dose Expansion) - No randomization

Group V: Module 1 / Part B1 Experimental Treatment 1 Intervention

AZD9750 Monotherapy (Dose Optimization) - Randomization

Group VI: Module 1 / Part A2 Experimental Treatment 1 Intervention

AZD9750 Monotherapy (Backfills) - No randomization

Group VII: Module 1 / Part A1 Experimental Treatment 1 Intervention

AZD9750 Monotherapy (Dose Escalation) - No randomization

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

1.

aacrjournals.org

aacrjournals.org/cancerres/article/85/8_Supplement_1/4758/760007/Abstract-4758-AZD9750-a-novel-androgen-receptor

Abstract 4758: AZD9750, a novel androgen receptor ...

Anti-tumor efficacy studies demonstrated that AZD9750 reduced tumor growth and in some cases caused tumor regression in a range of AR positive ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07336446?cond=cancer&term=algorithm+OR+%E2%80%9Cartificial+intelligence%E2%80%9D+OR+%E2%80%9Cconvolutional+network%E2%80%9D+OR+%E2%80%9Ccomputer+reasoning%E2%80%9D+OR+%E2%80%9Cvision+system%E2%80%9D+OR+%E2%80%9Cdeep+learning%E2%80%9D+OR+%E2%80%9CHierarchical+Learning%E2%80%9D+OR+%E2%80%9Cmachine+intelligence%E2%80%9D+OR+%E2%80%9Cmachine+learning%E2%80%9D+OR+%E2%80%9Cneural+network%E2%80%9D+OR+radiomics

NCT07336446 | A Trial to Learn How Safe AZD9750 is and ...

ANDROMEDA is a first-in-human, Phase I/II, open-label, multicenter study of AZD9750 in participants with metastatic prostate cancer.

3.

tipranks.com

tipranks.com/news/company-announcements/astrazeneca-advances-prostate-cancer-pipeline-with-new-andromeda-trial-on-azd9750

AstraZeneca Advances Prostate Cancer Pipeline With New ...

The study tests AZD9750, an oral cancer drug designed to target the androgen receptor pathway, a key driver of prostate cancer growth. It is ...

4.

aacrjournals.org

aacrjournals.org/cancerres/article/86/2_Supplement/B046/771657/Abstract-B046-AZD9750-a-novel-androgen-receptor

Abstract B046: AZD9750, a novel androgen receptor ...

In the MR041 hormone sensitive PDX model, AZD9750 significantly inhibited tumour growth, with the 10 and 30 mg/kg doses driving tumour ...

5.

withpower.com

withpower.com/trial/phase-2-bulbo-spinal-atrophy-x-linked-2026-a57c4

AZD9750 for Prostate Cancer (ANDROMEDA Trial)

The trial evaluates safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AZD9750 as monotherapy and in combination with ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07336446

NCT07336446 | A Trial to Learn How Safe AZD9750 is and ...

The trial evaluates safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AZD9750 as monotherapy and in combination with ...

7.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/37043746/astrazeneca-advances-prostate-cancer-pipeline-with-new-andromeda-trial-on-azd9750/

AstraZeneca Advances Prostate Cancer Pipeline With New ...

The ANDROMEDA trial is a Phase I/II study run by AstraZeneca to test a new prostate cancer drug called AZD9750 in men with metastatic disease.