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 States52 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 range18 Years
SexMALE
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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.
✓. 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
✕
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)
. 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.