AZD0516 for Prostate Cancer

(SEACLIFF Trial)

Recruiting at 41 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must be taking: GnRH modulators

Must not be taking: Corticosteroids, Chemotherapy

Disqualifiers: Spinal cord compression, Cardiovascular disorder, Active infection, others

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

Compensation: Varies

Number of Visits: Unknown

177 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new treatment called AZD0516 for individuals with metastatic prostate cancer that has spread beyond the prostate. The trial aims to assess the safety and tolerability of AZD0516, whether used alone or in combination with another treatment. Participants are divided into two groups: one receives only AZD0516, while the other receives AZD0516 with AZD9574. Men with confirmed metastatic prostate cancer who have undergone hormone therapy to lower testosterone levels may be suitable candidates for this trial. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial group, offering participants a chance to contribute to significant advancements in prostate cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, ongoing androgen deprivation therapy (ADT) must continue throughout the study if you haven't had a bilateral orchiectomy (surgical removal of both testicles).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is examining the safety of the treatment AZD0516, both alone and in combination with AZD9574. Limited information exists about the safety of AZD0516 from past studies. However, its progression to both early and later testing stages suggests that earlier tests deemed it safe enough for further study. If AZD0516 or AZD9574 were unsafe, they would not have advanced to this stage of testing.

Researchers are assessing whether these treatments cause harmful side effects and their severity. This ongoing research aims to determine if these treatments are safe for individuals with metastatic prostate cancer. Joining a clinical trial contributes to this important research on treatment safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AZD0516 for prostate cancer because it targets the androgen receptor pathway in a novel way, which is crucial for the growth of prostate cancer cells. Unlike the standard treatments that often involve hormone therapy or chemotherapy, AZD0516 provides a different approach by specifically inhibiting the proteins that help cancer cells survive. Additionally, in one arm of the trial, AZD0516 is combined with AZD9574, potentially enhancing its effectiveness and offering a new option for patients with metastatic castration-resistant prostate cancer (mCRPC) who may not respond well to existing therapies. This dual-approach could lead to better outcomes for patients who have exhausted other options.

What evidence suggests that AZD0516 might be an effective treatment for metastatic prostate cancer?

Research shows that AZD0516 is under investigation as a potential treatment for advanced prostate cancer. In this trial, participants will receive either AZD0516 alone or in combination with another drug, AZD9574. Although human studies on AZD0516 alone are limited, researchers are studying its ability to effectively target cancer cells. The combination with AZD9574 aims to enhance its cancer-fighting ability. These treatments target a type of prostate cancer that continues to grow despite lowered testosterone levels. Early laboratory studies have shown promise, suggesting these treatments might slow cancer growth. However, further research is needed to confirm these effects in people. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic prostate cancer. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a particular stage or progression of cancer.

Inclusion Criteria

Measurable PSA ≥ 1 μg/L (≥ 1 ng/mL)

Provision of baseline archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumour sample is mandatory

Life expectancy of at least 12 weeks in the opinion of the investigator

Exclusion Criteria

My brain or spinal cancer is stable, treated, and not causing symptoms.

I have had cancer spread to the lining of my brain and spinal cord.

I don't have serious side effects from past treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Module 1: Monotherapy

Participants receive AZD0516 as monotherapy, including dose escalation, dose optimisation, and efficacy expansion

Up to approximately 3 years

Treatment - Module 2: Combination Therapy

Participants receive AZD0516 in combination with AZD9574, including dose escalation and dose optimisation

Up to approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD0516

Trial Overview The study is evaluating the safety and tolerability of a drug called AZD0516 on its own (monotherapy) and when used together with other anti-cancer agents in treating metastatic prostate cancer.

How Is the Trial Designed?

Group I: Arm 2: AZD0516 + AZD9574 Experimental Treatment 2 Interventions

Participants with mCRPC will receive AZD0516 in combination with AZD9574.

Group II: Arm 1: AZD0516 monotherapy Experimental Treatment 1 Intervention

Participants with mCRPC will receive AZD0516 monotherapy.

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

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07181161

NCT07181161 | Study of AZD0516 as Monotherapy and in ... This is a first-in-human modular, Phase I/IIa, open-label, multi-centre study of AZD0516 in participants with metastatic prostate cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8249852/

Real-World Data on Outcomes in Metastatic Castrate ... Both abiraterone and enzalutamide have shown to improve overall survival (OS), progression-free survival (PFS) and prostate-specific antigen ...

3. astrazeneca.com astrazeneca.com/content/dam/az/PDF/2025/9m-q3/9M-and-Q3-2025-results-clinical-trials-appendix.pdf

9M and Q3 2025 results clinical trials appendix • Data anticipated: H2 2026. Phase III. PROpel. NCT03732820. 1L metastatic castration-resistant prostate cancer. 906. • Arm 1: Lynparza + ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT323749

Survival outcomes in patients with metastatic castration ... Results: The study included 1395 mCSPC men of which 874 (63%) were ADT only, 338 (24%) were ADT+AA (98% with bicalutamide), 75 (5%) were ADT+ABI, and 108 (8%) ...

5. medicaljournalssweden.se medicaljournalssweden.se/actaoncologica/article/view/42173

Real-world treatment patterns and survival outcomes in ... Median overall survival for treated patients with mCRPC was 28.3 (95% CI: 26.3–30.4) and 38.5 (95% CI: 32.7–42.1) months pre- and post- ...

6. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT07181161

University of California Health Prostate Cancer Trial The main purpose of this study is to assess the safety and tolerability of AZD0516 as monotherapy and/or in combination with other anti-cancer agents for ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12517898/

Systemic treatment of metastatic castration-sensitive prostate ... The results suggested that ADT combined with ARAT had a higher OS and PFS benefit compared to ADT alone and ADT + docetaxel. Moreover, our ...

8. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/metastatic-castration-resistant-prostate

Metastatic Castration-Resistant Prostate Cancer clinical trials ... This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating ...