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Prostate CancerPhase 1/2ACTIVATED-4-PCNCT07192614

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

A Phase 1/2 study testing AZD6621 in people with Prostate Cancer, run by AstraZeneca at 26 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
AZD6621
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
26 sitesin 9 countries
Study dates
30 Sep 2025to 29 Mar 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving signed informed consent 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 informed consent form.
  • Participants with:
  • Histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate
  • 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.
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  • Castration-resistant prostate cancer as defined by disease progression despite castration by orchiectomy or ongoing ADT.
  • PSA at screening visit ≥ 1 ng/mL.
  • Provision of baseline fresh or archival tumor biopsy of prostate carcinoma is mandatory.
  • Evidence of disease progression within 6 months prior to screening with at least one of the following:
  • PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination.
  • Radiographic progression of soft tissue disease by RECIST v1.1 criteria with or without PSA progression.
  • 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.
  • Part A: Module 1 and Module 2:
  • Part A: Module 1 and Module 2 prior anti-cancer treatment requirements as stated in study protocol
  • 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.
  • Part B: Module 1 and Module 2:
  • Part B: Module 1 and Module 2 prior anti-cancer treatment requirements as stated in study protocol.
  • Participants may have received PARP inhibitors or checkpoint inhibitors per local treatment guidelines.
  • Sampling Requirements as stated in study protocol.
  • ECOG PS score of 0 or 1.
  • Minimum life expectancy of > 12 weeks.
  • Adequate hematological, renal, bone marrow, and liver function as documented in the protocol.
  • Body weight ≥ 35 kg.
  • Male, as assigned at birth, inclusive of all gender identities.
  • Contraceptive use by participants or participant partners as documented in the protocol and consistent with local regulations.

Who cannot join

  • 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.
  • One or more of the following:
  • Mean resting corrected QT interval > 470 ms,
  • 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.
  • Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives.
  • Inadequate cardiac function of LVEF < 50% on screening cardiac MUGA or ECHO.
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  • 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.
  • 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.
  • History of, or planned organ or allogeneic stem cell transplantation.
  • Unresolved toxicity from prior anti-cancer therapy of CTCAE Grade ≥ 2 (exceptions listed in protocol).
  • History of Grade ≥ 3 CRS or Grade ≥ 2 ICANS based on ASTCT criteria with prior therapy. CRS must be resolved prior to screening.
  • Previous history of hemophagocytic lymphohistiocytosis/ macrophage activation syndrome.
  • 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.
  • Spinal cord compression unless asymptomatic and treated and stable and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent.
  • CNS pathology (examples in protocol).
  • Active or uncontrolled hepatitis B or C virus infection (exceptions listed in the protocol).
  • Known HIV infection that is not well controlled (definition for HIV infection that is well controlled is listed in protocol).
  • Radiation therapy within 4 weeks of first dose of study intervention (or local or focal radiotherapy within 2 weeks of first dose).
  • Prior anti-cancer drug exposure requirement as stated in study protocol
  • Previous anti-cancer treatment requirements as stated in study protocol
  • Systemic corticosteroids at doses exceeding 10 mg/day of prednisone or equivalent < 7 days prior to first dose.
  • Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose.
  • 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.
  • Participants with a known hypersensitivity to AZD6621 or any of its excipients.
  • Involvement in the planning and/or conduct of the study.
  • Participant is unlikely to comply with study procedures, restrictions, and requirements (as judged by the Investigator).
  • 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.
  • Previous enrolment in the present study.

Trial locations and contacts

26 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

26 sites in 9 countries

United States6 sites, 5 recruiting

  • Research Site

    Boston, Massachusetts, 02114

    Withdrawn

  • Research Site

    Commack, New York, 11725

    Recruiting

  • Research Site

    Grand Rapids, Michigan, 49546

    Recruiting

  • Research Site

    Orlando, Florida, 32806

    Recruiting

  • Research Site

    Providence, Rhode Island, 02903

    Recruiting

  • Research Site

    Tampa, Florida, 33612

    Recruiting

Other trials in United States

China4 sites, 2 recruiting

  • Research Site

    Beijing, 100142

    Recruiting

  • Research Site

    Chengdu, 610041

    Suspended

  • Research Site

    Guangzhou, 510060

    Suspended

  • Research Site

    Nanjing, 2100008

    Not yet recruiting

Other trials in China

Japan3 sites, 3 recruiting

  • Research Site

    Chūōku, 104-0045

    Recruiting

  • Research Site

    Hirakata-shi, 573-1191

    Recruiting

  • Research Site

    Kashiwa, 277-8577

    Recruiting

Other trials in Japan

Spain3 sites, 3 recruiting

  • Research Site

    Barcelona, 8035

    Not yet recruiting

  • Research Site

    L'Hospitalet de Llobregat, 08908

    Not yet recruiting

  • Research Site

    Madrid, 28041

    Recruiting

Other trials in Spain

Belgium2 sites, 2 recruiting

  • Research Site

    Brussels, 1200

    Not yet recruiting

  • Research Site

    Ghent, 9000

    Not yet recruiting

Other trials in Belgium

Canada2 sites, 2 recruiting

  • Research Site

    Québec, G1J 1Z4

    Recruiting

  • Research Site

    Toronto, Ontario, M4N 3M5

    Not yet recruiting

Other trials in Canada

Netherlands2 sites, 2 recruiting

  • Research Site

    Amsterdam, 1066CX

    Not yet recruiting

  • Research Site

    Maastricht, 6229 HX

    Not yet recruiting

Other trials in Netherlands

South Korea2 sites, 2 recruiting

  • Research Site

    Seoul, 03080

    Recruiting

  • Research Site

    Seoul, 5505

    Recruiting

Other trials in South Korea

United Kingdom2 sites, 2 recruiting

  • Research Site

    Cambridge, CB2 0QQ

    Recruiting

  • Research Site

    Manchester, M20 4BX

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Phase I/II Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6621, a T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8 in Adult Participants With Metastatic Prostate Cancer

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).

Read the detailed description

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.

Conditions
Prostate Cancer
Being tested
AZD6621
Keywords
Metastatic Prostate Cancer, Prostate Cancer, Prostate Adenocarcinoma, T Cell-engaging Antibody, STEAP2, CD3, CD8
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD6621Drug

    A T Cell-engaging Antibody that targets STEAP2, CD3, and CD8

Study groups in NCT07192614
Study groupRoleWhat they receive
Module 1 - Part A (Dose Escalation)ExperimentalAZD6621 Monotherapy - Administration route 1
Receives: Drug: AZD6621
Module 2 - Part A (Dose Escalation)ExperimentalAZD6621 Monotherapy - Administration route 2
Receives: Drug: AZD6621
Module 1/2 - Part B1 (Dose Expansion)ExperimentalAZD6621 Monotherapy - Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)
Receives: Drug: AZD6621
Module 1/2 - Part B2 (Dose Expansion)ExperimentalAZD6621 Monotherapy - Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)
Receives: Drug: AZD6621

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE)

    • Number of participants with AEs, AESIs, SAEs, including AEs leading to discontinuation of study intervention and clinically significant alterations from baseline in laboratory parameters, vital signs, ECGs and physical examination results

    Measured: From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years)

  2. Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)

    • A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.

    Measured: From first study dose to 21 to 28 days post first dose

  3. Preliminary anti-tumour activity of AZD6621 (PSA Response Rate) (Part B only)

    • Number of participants with a PSA response rate

    Measured: Up to 3 years

Secondary outcomes (17)

  1. Preliminary anti-tumour activity of AZD6621 (PSA Response rate) (Part A only)

    • Number of participants with a PSA response rate

    Measured: Up to 3 years

  2. Preliminary anti-tumour activity of AZD6621 (time to PSA response)

    • Time taken to achieve a PSA response

    Measured: Up to 3 years

  3. Preliminary anti-tumour activity of AZD6621 (duration of PSA response)

    • Time PSA response lasts

    Measured: Up to 3 years

  4. Preliminary anti-tumour activity of AZD6621 (durable PSA response rate)

    • Percentage of participants who have a confirmed PSA response with a duration of at least 6 months

    Measured: Up to 3 years

  5. Preliminary anti-tumour activity of AZD6621 (time to PSA progression)

    • Time taken to achieve PSA progression

    Measured: Up to 3 years

  6. Preliminary anti-tumour activity of AZD6621 (Radiological Response - RECIST)

    • Radiological response: according to RECIST v1.1 (soft tissue) and PCWG3 (bone)

    Measured: Up to 3 years

  7. Preliminary anti-tumour activity of AZD6621 (Radiological Response - Target Lesion Percentage change)

    • Percentage change in Target Lesion size according to RECIST v1.1.

    Measured: Up to 3 years

  8. Preliminary anti-tumour activity of AZD6621 (Overall Survival 12 months)

    • Overall Survival at 12 months

    Measured: 12 months

  9. Preliminary anti-tumour activity of AZD6621 (Overall Survival)

    • Median Overall Survival

    Measured: Up to 3 years

  10. Preliminary anti-tumour activity of AZD6621 (SSRE)

    • Time to first symptomatic skeletal-related events (SSRE)

    Measured: Up to 3 years

  11. Pharmacokinetics of AZD6621 (Serum concentrations)

    • Serum concentrations of the study drug.

    Measured: From first dose of study intervention to 28 days post last dose of study intervention

  12. Pharmacokinetics of AZD6621 (Cmax)

    • Maximum observed plasma concentration of the study drug (Cmax).

    Measured: From first dose of study intervention to 28 days post last dose of study intervention

  13. Pharmacokinetics of AZD6621 (AUC)

    • Area under the plasma concentration-time curve (AUC).

    Measured: From first dose of study intervention to 28 days post last dose of study intervention

  14. Pharmacokinetics of AZD6621 (Tmax)

    • The time it takes for study drug to reach the maximum concentration (Tmax).

    Measured: From first dose of study intervention to 28 days post last dose of study intervention

  15. Pharmacokinetics of AZD6621 (t1/2)

    • Terminal elimination half life of study drug (t1/2)

    Measured: From first dose of study intervention to 28 days post last dose of study intervention

  16. Immunogenicity of AZD6621

    • The number and percentage of participants who develop detectable anti-drug antibodies (ADA).

    Measured: From first dose of study intervention to 28 days post last dose of study intervention

  17. Tumour STEAP2 expression

    • STEAP2 expression in tumour as measured by immunohistochemistry (IHC)

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2025
  2. Study start30 Sep 2025
  3. Primary completion29 Mar 2029 (estimated)
  4. Study completion29 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
This is a first in human, multicenter, open-label, dose-escalation and dose-expansion study. The study includes 2 Modules; Module 1 is investigating AZD6621 given on its own by one method of administration, and Module 2 is investigating AZD6621 on its own by a different method of administration. The study also has 2 parts: Part A Dose Escalation and Part B Dose Expansion. Part B Dose expansion will assess at least 2 doses or dosing schedules in either module. Participants will be randomised in Part B to one of these cohorts whenever possible
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07192614
Sponsor's protocol ID
D8020C00003
Other IDs
2025-520626-37, 2025
Acronym
ACTIVATED-4-PC
Status last verified
Aug 2026
First submitted
11 Jul 2025
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AZD6621 in people with Prostate Cancer, run by AstraZeneca at 26 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, China, Japan, Spain, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE) (time frame: From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07192614.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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