Recruiting

ACTIVATED-4-PCAZD6621 Antibody for Metastatic Prostate Cancer

What is being tested

AZD6621

Drug

Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years

+44 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: September 2025

See protocol details

Summary

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 30, 2025

Actual date on which the first participant was enrolled.

This study focuses on evaluating a new treatment called AZD6621 for adults with metastatic prostate cancer. Metastatic prostate cancer is a form of cancer that has spread beyond the prostate gland to other parts of the body. This research is important because it aims to find out how safe and effective AZD6621 is, as well as how it interacts with the body. By understanding these aspects, the study hopes to contribute to better treatment options for patients with this condition. Participants in the study will receive AZD6621, a T cell-engaging antibody, which targets specific proteins involved in cancer growth. The study will take place across various locations and will be divided into modules that explore different aspects, such as safety and how the drug behaves in the body. The research team will closely monitor participants to assess the treatment's anti-tumor activity and any potential immune responses it might trigger. This approach helps ensure the treatment's safety and effectiveness for future use.

Official TitleA 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

NCT07192614

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

20 inclusion criteria required to participate

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.

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 prior anti-cancer treatment requirements as stated in study protocol.

Show More Criteria

24 exclusion criteria prevent from participating

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.

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.

Prior anti-cancer drug exposure requirement as stated in study protocol.

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

AZD6621 Monotherapy - Administration route 1

Group II

Experimental

AZD6621 Monotherapy - Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)

Group III

Experimental

AZD6621 Monotherapy - Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)

Group IV

Experimental

AZD6621 Monotherapy - Administration route 2

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 13 locations

Recruiting

Research Site

Grand Rapids, United StatesOpen Research Site in Google Maps

Recruiting

Research Site

Providence, United States

Recruiting

Research Site

Hirakata-shi, Japan

Recruiting

Research Site

Seoul, South Korea

Recruiting

13 Study Centers