At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AZD6621 (drug)
- How long the study runs
- Study runs about 42 months (dates as stated)
- About the drug or intervention
- AZD6621 — drug: A T Cell-engaging Antibody that targets STEAP2, CD3, and CD8
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by AstraZeneca, looks at how safe an experimental drug called AZD6621 is, how well it works, and how it moves through the body over time. It is for adult men with metastatic prostate cancer — prostate cancer that has spread — which has stopped responding to standard hormone treatment (called castration-resistant prostate cancer).
Who can take part
- Men aged 18 or over (assigned male at birth, inclusive of all gender identities)
- Metastatic prostate cancer confirmed by a tissue sample, which has got worse despite hormone treatment or surgery to lower testosterone
- A PSA blood test result of at least 1 ng/mL at screening
- Evidence the cancer has got worse in the last 6 months — shown by rising PSA levels, scans, or new bone lesions
- Willing and able to give a tumour biopsy sample
- Able to walk about and carry out light activity (performance status score of 0 or 1)
- Life expectancy of at least 12 weeks
- Good blood, kidney, bone marrow and liver function
- Body weight at least 35 kg
- Willing to use contraception, if needed, as set out in the study
Who may not be able to
- Other serious health problems that would make taking part unsafe, in the doctor's view
- Certain heart problems, such as a long QT interval on a heart trace, congenital long QT syndrome, some abnormal heart rhythms, or poor heart pumping function
- Another cancer in the last 2 years, unless treated with a low risk of coming back
- Past or planned organ or stem cell transplant
- Ongoing moderate or worse side effects from earlier cancer treatment
- Past severe immune reactions to treatment, such as cytokine release syndrome or a condition affecting the brain (ICANS), or a history of haemophagocytic lymphohistiocytosis/macrophage activation syndrome
- Active autoimmune or inflammatory disease within the past 3 years, or needing long-term immune-suppressing medicine
- Spinal cord compression that is not treated and stable, or needing more than 10 mg prednisone (or equivalent) a day
- Certain brain or nervous system conditions
- Active hepatitis B or C infection, or HIV that is not well controlled
- Radiotherapy in the last 4 weeks (or 2 weeks for targeted radiotherapy)
- More than 10 mg prednisone (or equivalent) a day in the 7 days before the first dose
- Major surgery or serious injury in the last 4 weeks
- Cancer treatment or another clinical trial drug in the last 21 days (or 5 half-lives, if shorter), or CAR-T cell therapy in the last 6 months
- Allergic reaction to AZD6621 or any of its ingredients
- Live vaccines in the last 30 days, or a COVID-19 vaccine in the last 72 hours before the first dose
- Being unable to follow the study rules, in the doctor's view, or having taken part in this study before
What taking part involves
- • Taking the study drug AZD6621 — the exact dose and how it is given is not stated — ask the trial team
- • The study has different parts and modules (Part A and Part B), with rules about previous cancer treatments — ask the trial team for details
- • Providing a tumour biopsy (either a fresh sample or one stored from before)
- • Some people in a special group will need an extra biopsy of a tumour area that can be safely sampled
- • Blood tests and scans to check safety, how well the drug works, and how it moves through the body
- • Extra details on tests and sampling are in the study protocol — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 52
- Started
- 2025-09-30
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer
- • Phase1/Phase2 - 52 participants
- • This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD6621
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer
- • Male only
Where?
- • Cambridge - Research Site
- • Manchester - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About 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 AZD6621. The study is split into different modules which will look at AZD6621 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels of AZD6621 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 AZD6621 doses in a larger group of participants (dose expansion).
More detail
This is a first in human, modular, Phase I/II, open-label, multicenter study of AZD6621, in adult participants with metastatic prostate cancer. The study will consist of study modules, each evaluating safety, tolerability, PK, pharmacodynamics, and anti-tumor activity of AZD6621 in metastatic prostate cancer. The study will also characterize the PK and immunogenicity of AZD6621.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ treatment unless controlled by pacemaker
What the study is looking for
- ✓Inclusion Criteria
- ✓Capable of giving signed agreement to take part and complying to the study protocol.
- ✓Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form.
- ✓≥ 18 years of age at the time of signing the agreement to take part form.
- ✓Participants with:
See the full criteria
Where Is This Study? (2 UK sites)
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
