A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Ove… (NCT07192614) | Clinical Trial Compass
RecruitingPhase 1/2
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
United States, Belgium, Canada52 participantsStarted 2025-09-30
Plain-language 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. 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).
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE)
Timeframe: 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)
Timeframe: 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)
. Castration-resistant prostate cancer as defined by disease progression despite castration by orchiectomy or ongoing ADT.
. PSA at screening visit ≥ 1 ng/mL.
Exclusion criteria
. 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.
. 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.