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Looking for participantsPhase1/Phase2

A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer

Sponsor: AstraZeneca

NCT ID: NCT07192614

View on ClinicalTrials.gov ↗

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.

Prostate Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

PSA

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
Inclusion Criteria 1. Capable of giving signed informed consent and complying to the study protocol. 2. Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form. 3. ≥ 18 years of age at the time of signing the informed consent form. 4. Participants with: 1. Histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate 2. Surgically or medically castrated, with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) ≤ 28 days before first dose of study intervention. Participants without prior surgical castration must be currently taking and willing to continue LHRH agonist or antagonist therapy throughout the duration of the study intervention. 3. Castration-resistant prostate cancer as defined by disease progression despite castration by orchiectomy or ongoing ADT. 4. PSA at screening visit ≥ 1 ng/mL. 5. Provision of baseline fresh or archival tumor biopsy of prostate carcinoma is mandatory. 6. Evidence of disease progression within 6 months prior to screening with at least one of the following: 1. PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination. 2. Radiographic progression of soft tissue disease by RECIST v1.1 criteria with or without PSA progression. 3. Radiographic progression of bone metastasis by PCWG3 criteria with 2 or more documented new bone lesions on a bone scan with or without PSA progression. 7. Part A: Module 1 and Module 2: 1. Part A: Module 1 and Module 2 prior anti-cancer treatment requirements as stated in study protocol 2. Pharmacodynamic backfill cohort(s) only: lesion amenable for biopsy and be willing to undergo biopsy, distinct from any target lesion used in the RECIST v1.1 evaluation, unless there are no other lesions available for biopsy. 8. Part B: Module 1 and Module 2: 1. Part B: Module 1 and Module 2 prior anti-cancer treatment requirements as stated in study protocol. 2. Participants may have received PARP inhibitors or checkpoint inhibitors per local treatment guidelines. 3. Sampling Requirements as stated in study protocol. 9. ECOG PS score of 0 or 1. 10. Minimum life expectancy of \> 12 weeks. 11. Adequate hematological, renal, bone marrow, and liver function as documented in the protocol. 12. Body weight ≥ 35 kg. 13. Male, as assigned at birth, inclusive of all gender identities. 14. Contraceptive use by participants or participant partners as documented in the protocol and consistent with local regulations. Exclusion Criteria 1. Any evidence of diseases (such as severe or uncontrolled systemic diseases) which in the Investigator's opinion makes it undesirable for the participant to participate in the study. 2. One or more of the following: 1. Mean resting corrected QT interval \> 470 ms, 2. History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes. 3. Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives. 4. Inadequate cardiac function of LVEF \< 50% on screening cardiac MUGA or ECHO. 3. Cardiac arrhythmias (such as multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which are symptomatic or require treatment unless controlled by pacemaker; symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. 4. History of another primary malignancy except for malignancy treated with curative intent with no known active disease (≥ 2 years) before the first dose of study intervention and of low potential risk for recurrence. 5. History of, or planned organ or allogeneic stem cell transplantation. 6. Unresolved toxicity from prior anti-cancer therapy of CTCAE Grade ≥ 2 (exceptions listed in protocol). 7. History of Grade ≥ 3 CRS or Grade ≥ 2 ICANS based on ASTCT criteria with prior therapy. CRS must be resolved prior to screening. 8. Previous history of hemophagocytic lymphohistiocytosis/ macrophage activation syndrome. 9. Active or prior documented autoimmune or inflammatory disorders (examples in protocol) within the past 3 years prior to the start of treatment or requiring permanent immunosuppressive therapy. 10. Spinal cord compression unless asymptomatic and treated and stable and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent. 11. CNS pathology (examples in protocol). 12. Active or uncontrolled hepatitis B or C virus infection (exceptions listed in the protocol). 13. Known HIV infection that is not well controlled (definition for HIV infection that is well controlled is listed in protocol). 14. Radiation therapy within 4 weeks of first dose of study intervention (or local or focal radiotherapy within 2 weeks of first dose). 15. Prior anti-cancer drug exposure requirement as stated in study protocol 16. Previous anti-cancer treatment requirements as stated in study protocol 17. Systemic corticosteroids at doses exceeding 10 mg/day of prednisone or equivalent \< 7 days prior to first dose. 18. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose. 19. Receipt of the last dose of anti-cancer therapy or participation in another clinical study with last dose administered in the last 21 days or 5 half-lives, whichever is shorter \- CAR-T cell therapy within the last 6 months prior to enrolment on this study. 20. Participants with a known hypersensitivity to AZD6621 or any of its excipients. 21. Involvement in the planning and/or conduct of the study. 22. Participant is unlikely to comply with study procedures, restrictions, and requirements (as judged by the Investigator). 23. Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention or receipt of COVID-19 vaccination within 72 hours prior to the first dose of study intervention. 24. Previous enrolment in the present study.

Where Is This Study? (2 UK sites)

Research Site

Cambridge CB2 0QQ, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08