Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-05-07
52
Participants Needed
25
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and follow study procedures.
- Signed Optional Genomics Initiative Research Information and Consent Form.
- 18 years of age or older at time of consent.
- Histologically confirmed metastatic adenocarcinoma of the prostate.
- Surgically or medically castrated with serum testosterone ≤ 50 ng/dL within 28 days before first dose; if not surgically castrated, currently taking and willing to continue LHRH therapy.
- Castration-resistant prostate cancer with disease progression despite castration.
- PSA level ≥ 1 ng/mL at screening.
- Provision of baseline fresh or archival prostate tumor biopsy.
- Evidence of disease progression within 6 months before screening by PSA or radiographic criteria.
- Meet prior anti-cancer treatment requirements per protocol for Part A and Part B modules.
- ECOG performance status score of 0 or 1.
- Minimum life expectancy greater than 12 weeks.
- Adequate blood, kidney, bone marrow, and liver function per protocol.
- Body weight at least 35 kg.
- Male assigned at birth, inclusive of all gender identities.
- Use of contraception by participant or partner as per protocol and local regulations.
You will not qualify if you...
- Any severe or uncontrolled systemic disease judged unsuitable by the Investigator.
- Mean resting corrected QT interval > 470 ms or history of QT prolongation requiring treatment discontinuation.
- Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under age 40 in first-degree relatives.
- Cardiac function with left ventricular ejection fraction below 50%.
- Symptomatic or untreated cardiac arrhythmias requiring treatment, except if controlled by pacemaker.
- History of other primary malignancies unless treated with curative intent and no known active disease for at least 2 years.
- History or planned organ or allogeneic stem cell transplantation.
- Unresolved toxicity from prior anti-cancer therapy of Grade 2 or higher.
- History of severe cytokine release syndrome or immune-related neurotoxicity from prior therapy.
- Previous hemophagocytic lymphohistiocytosis or macrophage activation syndrome.
- Active or prior autoimmune or inflammatory disorders within 3 years requiring permanent immunosuppressive therapy.
- Spinal cord compression unless stable and not requiring high-dose corticosteroids.
- Central nervous system pathology as defined in protocol.
- Active or uncontrolled hepatitis B or C infection.
- Known HIV infection not well controlled.
- Recent radiation therapy within 4 weeks or focal radiotherapy within 2 weeks before first dose.
- Prior anti-cancer drug exposure not meeting protocol requirements.
- Use of systemic corticosteroids exceeding 10 mg/day prednisone or equivalent within 7 days before first dose.
- Major surgery or significant injury within 4 weeks before first dose.
- Recent anti-cancer therapy or clinical study participation within 21 days or 5 half-lives, whichever is shorter.
- CAR-T cell therapy within 6 months before enrollment.
- Known allergy to AZD6621 or its ingredients.
- Involvement in study planning or conduct.
- Unlikely to comply with study procedures.
- Receipt of live attenuated vaccine within 30 days or COVID-19 vaccine within 72 hours before first dose.
- Previous enrollment in this study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Research Site
Orlando, Florida, United States, 32806
Not Yet Recruiting
2
Research Site
Tampa, Florida, United States, 33612
Actively Recruiting
3
Research Site
Boston, Massachusetts, United States, 02114
Withdrawn
4
Research Site
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
5
Research Site
Commack, New York, United States, 11725
Actively Recruiting
6
Research Site
Providence, Rhode Island, United States, 02903
Actively Recruiting
7
Research Site
Ghent, Belgium, 9000
Not Yet Recruiting
8
Research Site
Toronto, Ontario, Canada, M4N 3M5
Not Yet Recruiting
9
Research Site
Québec, Canada, G1J 1Z4
Not Yet Recruiting
10
Research Site
Beijing, China, 100142
Not Yet Recruiting
11
Research Site
Chengdu, China, 610041
Suspended
12
Research Site
Guangzhou, China, 510060
Suspended
13
Research Site
Nanjing, China, 2100008
Not Yet Recruiting
14
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
15
Research Site
Hirakata-shi, Japan, 573-1191
Actively Recruiting
16
Research Site
Kashiwa, Japan, 277-8577
Not Yet Recruiting
17
Research Site
Amsterdam, Netherlands, 1066CX
Not Yet Recruiting
18
Research Site
Maastricht, Netherlands, 6229 HX
Not Yet Recruiting
19
Research Site
Seoul, South Korea, 03080
Actively Recruiting
20
Research Site
Seoul, South Korea, 5505
Actively Recruiting
21
Research Site
Barcelona, Spain, 8035
Not Yet Recruiting
22
Research Site
L'Hospitalet de Llobregat, Spain, 08908
Not Yet Recruiting
23
Research Site
Madrid, Spain, 28041
Not Yet Recruiting
24
Research Site
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
25
Research Site
Manchester, United Kingdom, M20 4BX
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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