Actively Recruiting
Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer
Led by AstraZeneca · Updated on 2026-05-08
177
Participants Needed
52
Research Sites
172 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of this study is to assess the safety and tolerability of AZD0516 as monotherapy and/or in combination with other anti-cancer agents for treatment of metastatic prostate cancer.
CONDITIONS
Official Title
Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic adenocarcinoma of the prostate, including focal high grade neuroendocrine features
- PSA level of at least 1 ng/mL (1 g/L) measurable
- Surgically or medically castrated with serum testosterone 50 ng/dL within 28 days before treatment
- Ongoing androgen deprivation therapy with a GnRH modulator started at least 2 weeks before consent and continued throughout the study if no bilateral orchiectomy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function without recent blood transfusion or growth factor support
- Provision of baseline archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumor sample
- Documented current evidence of metastatic prostate cancer
- Life expectancy of at least 12 weeks per investigator judgment
- Documented metastatic castration-resistant prostate cancer (mCRPC) progression at screening by one or more of:
- PSA progression with at least 3 rising PSA levels spaced a week apart and screening PSA 1 ng/mL
- Soft tissue radiographic progression by RECIST v1.1 criteria with or without PSA progression
- Bone scan showing 2 or more new bone lesions with or without PSA progression
You will not qualify if you...
- Cancer-related spinal cord compression or brain metastases unless asymptomatic, treated, stable, and not needing corticosteroids 10 mg prednisone/day for 4 weeks before enrollment
- History of leptomeningeal carcinomatosis
- Unresolved toxicities grade 2 from prior therapy (except controlled vitiligo, alopecia, and hormone disorders)
- Uncontrolled illness within the last 12 months
- Cardiovascular disorders including arrhythmia, uncontrolled hypertension, symptomatic hypotension, brain perfusion issues, symptomatic heart failure, cardiomyopathy, or severe valvular heart disease
- History of other malignancies
- History of non-infectious interstitial lung disease or pneumonitis
- Active infections including tuberculosis, hepatitis B or C, or HIV
- Known bleeding predisposition
- Severe lung problems
- Myelodysplastic syndrome or acute myeloid leukemia or features suggesting these
- Previous treatment with STEAP2 targeting agents, topoisomerase inhibitors, or metabolic enzyme inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
Research Site
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
2
Research Site
Los Angeles, California, United States, 90095
Actively Recruiting
3
Research Site
Towson, Maryland, United States, 21204
Suspended
4
Research Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Research Site
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
Research Site
Detroit, Michigan, United States, 48201
Actively Recruiting
7
Research Site
Buffalo, New York, United States, 14263
Suspended
8
Research Site
New York, New York, United States, 10065
Actively Recruiting
9
Research Site
Providence, Rhode Island, United States, 02906
Actively Recruiting
10
Research Site
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
11
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
12
Research Site
Barretos, Brazil, 14784-400
Not Yet Recruiting
13
Research Site
Porto Alegre, Brazil, 90035-001
Not Yet Recruiting
14
Research Site
São Paulo, Brazil, 01401-002
Not Yet Recruiting
15
Research Site
Changsha, China, 410013
Not Yet Recruiting
16
Research Site
Chengdu, China, 610041
Not Yet Recruiting
17
Research Site
Wuhan, China, 430022
Not Yet Recruiting
18
Research Site
Lyon, France, 69008
Withdrawn
19
Research Site
Montpellier, France, 34298
Withdrawn
20
Research Site
Saint-Herblain, France, 44805
Withdrawn
21
Research Site
Suresnes, France, 92151
Withdrawn
22
Research Site
Villejuif, France, 94805
Withdrawn
23
Research Site
Milan, Italy, 20132
Not Yet Recruiting
24
Research Site
Milan, Italy, 20133
Not Yet Recruiting
25
Research Site
Milan, Italy, 20141
Not Yet Recruiting
26
Research Site
Naples, Italy, 80131
Not Yet Recruiting
27
Research Site
Roma, Italy, 00168
Not Yet Recruiting
28
Research Site
Rozzano, Italy, 20089
Not Yet Recruiting
29
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
30
Research Site
Kashiwa, Japan, 277-8577
Not Yet Recruiting
31
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
32
Research Site
Koszalin, Poland, 75-581
Not Yet Recruiting
33
Research Site
Piotrkow Trybunalski, Poland, 97-300
Not Yet Recruiting
34
Research Site
Przemyśl, Poland, 37-700
Not Yet Recruiting
35
Research Site
Seoul, South Korea, 03080
Not Yet Recruiting
36
Research Site
Seoul, South Korea, 03722
Actively Recruiting
37
Research Site
Seoul, South Korea, 06351
Actively Recruiting
38
Research Site
Seoul, South Korea, 06591
Not Yet Recruiting
39
Research Site
Seoul, South Korea, 5505
Not Yet Recruiting
40
Research Site
Barcelona, Spain, 08035
Actively Recruiting
41
Research Site
Barcelona, Spain, 08036
Not Yet Recruiting
42
Research Site
Barcelona, Spain, 08041
Not Yet Recruiting
43
Research Site
L'Hospitalet de Llobregat, Spain, 08908
Not Yet Recruiting
44
Research Site
Madrid, Spain, 28027
Actively Recruiting
45
Research Site
Pamplona, Spain, 31005
Actively Recruiting
46
Research Site
Santander, Spain, 39008
Not Yet Recruiting
47
Research Site
Valencia, Spain, 46009
Not Yet Recruiting
48
Research Site
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
49
Research Site
London, United Kingdom, EC1A 7BE
Not Yet Recruiting
50
Research Site
London, United Kingdom, SE1 9RT
Not Yet Recruiting
51
Research Site
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
52
Research Site
Sutton, United Kingdom, SM2 5PT
Actively 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
2
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