RecruitingPhase 1 / Phase 2

Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Metastatic Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 130 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of AZD0516 alone or with other cancer drugs. It is for people with prostate cancer that has spread to other parts of the body and is getting worse despite treatment to lower testosterone.

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 treatment of metastatic prostate cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tests of tissue or cells must confirm prostate adenocarcinoma, a type of prostate cancer. There must be current proof that it has spread.
  • PSA, a blood marker for prostate cancer, must be at least 1 ng/mL.
  • Testosterone must be 50 ng/dL or less within 28 days before treatment assignment. If both testicles have not been removed, hormone-lowering treatment must start at least 2 weeks before consent and continue during the study.
  • You must be fully active or able to do light work, even if hard physical activity is limited.
  • Your organs and bone marrow must work well enough, without a blood transfusion or drugs that boost blood cell growth in the 21 days before the first study dose.
  • You must provide a stored or newly collected tumor tissue sample.
  • The study doctor must expect you to live at least 12 weeks.
  • Your cancer must be getting worse despite low testosterone. This must be shown by 3 rising PSA results at least a week apart, scans showing growth in soft tissue, or at least 2 new spots of cancer in bone.

Who can't join

  • Cancer pressing on the spinal cord or spread to the brain, unless treated, stable, and causing no symptoms, with no ongoing steroid dose above 10 mg of prednisone a day or equal for at least 4 weeks before joining. Past cancer in the lining around the brain or spinal cord also excludes you.
  • Moderate or worse side effects from past treatment that have not gone away. Exceptions include loss of skin color, hair loss, and hormone problems controlled with replacement hormones.
  • An uncontrolled illness in the past 12 months, certain heart or blood vessel problems, or a history of cancer.
  • Past lung inflammation not caused by infection, or severe breathing problems.
  • Active infections covered by the study rules, including tuberculosis, hepatitis B, hepatitis C, or HIV.
  • A known tendency to bleed.
  • Myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), which affect blood-forming cells, or signs suggesting either condition.
  • Past treatment aimed at a target called STEAP2, or chemotherapy that blocks topoisomerase or metabolic enzymes.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Main Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are permitted. * Measurable PSA ≥ 1 μg/L (≥ 1 ng/mL). * Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) within ≤ 28 days before treatment allocation. Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) modulator for participants who have not undergone bilateral orchiectomy must be initiated at least 2 weeks prior to consent and must continue throughout the study. * Eastern cooperative oncology group (ECOG) performance status of 0 or 1. * Adequate organ and marrow function in the absence of blood transfusion or growth factor support (within 21 days prior to the scheduled first dose of study intervention). * Provision of baseline archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumour sample is mandatory. * Documented current evidence of metastatic prostate cancer * Life expectancy of at least 12 weeks in the opinion of the investigator * Documented mCRPC progression at screening as assessed by the investigator with at least one of the following criteria: 1. PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the screening visit should be ≥ 1 μg/L (1 ng/mL). 2. Radiographic disease progression in soft tissue based on response evaluation criteria in solid tumors (RECIST) v1.1 criteria with or without PSA progression as per prostate cancer working group 3 (PCWG3). 3. Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on a bone scan as per PCWG3 with or without PSA progression. Main Exclusion Criteria: * Cancer related spinal cord compression, or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to study enrolment. * History of leptomeningeal carcinomatosis. * Unresolved toxicities of Grade ≥ 2 (National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy). * Uncontrolled intercurrent illness within the last 12 months. * Cardiovascular disorder (History of arrhythmia, uncontrolled hypertension, symptomatic hypotension, history of brain perfusion problems, symptomatic heart failure, prior or current cardiomyopathy, severe valvular heart disease) * History of malignancy * History of non-infectious interstitial lung disease (ILD)/pneumonitis * Active infection exclusions, including tuberculosis and infections with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV). * Any known predisposition to bleeding * Clinically severe pulmonary compromise * Participants with Myelodysplastic syndrome (MDS)/Acute Myeloid Leukemia (AML) or with features suggestive of MDS/AML. * Previous treatment with a STEAP2 targeting modality, chemotherapeutic agent that inhibits topoisomerase activity or metabolic enzymes.

Study sites (11)

AR

CA

MA

MD

MI

NY

RI

SC

TX