AZD0516: AZD0516 will be administered via intravenous infusion.
AZD9574: AZD9574 will be administered orally.
Study summary
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Main Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are permitted.
* Measurable PSA ≥ 1 μg/L (≥ 1 ng/mL).
* Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) within ≤ 28 days before treatment allocation. Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) modulator for participants who have not undergone bilateral orchiectomy must be initiated at least 2 weeks prior to consent and must continue throughout the study.
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
* Adequate organ and marrow function in the absence of blood transfusion or growth factor support (within 21 days prior to the scheduled first dose of study intervention).
* Provision of baseline archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumour sample is mandatory.
* Documented current evidence of metastatic prostate cancer
* Life expectancy of at least 12 weeks in the opinion of the investigator
* Documented mCRPC progression at screening as assessed by the investigator with at least one of the following criteria:
1. PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the screening visit should be ≥ 1 μg/L (1 ng/mL).
2. Radiographic disease progression in soft tissue based on response evaluation criteria in solid tumors (RECIST) v1.1 criteria with or without PSA progression as per prostate cancer working group 3 (PCWG3).
3. Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on a bone scan as per PCWG3 with or without PSA progression.
Main Exclusion Criteria:
* Cancer related spinal cord compression, or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to study enrolment.
* History of leptomeningeal carcinomatosis.
* Unresolved toxicities of Grade ≥ 2 (National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy).
* Uncontrolled intercurrent illness within the last 12 months.
* Cardiovascular disorder (History of arrhythmia, uncontrolled hypertension, symptomatic hypotension, history of brain perfusion problems, symptomatic heart failure, prior or current cardiomyopathy, severe valvular heart disease)
* History of malignancy
* History of non-infectious interstitial lung disease (ILD)/pneumonitis
* Active infection exclusions, including tuberculosis and infections with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
* Any known predisposition to bleeding
* Clinically severe pulmonary compromise
* Participants with Myelodysplastic syndrome (MDS)/Acute Myeloid Leukemia (AML) or with features suggestive of MDS/AML.
* Previous treatment with a STEAP2 targeting modality, chemotherapeutic agent that inhibits topoisomerase activity or metabolic enzymes.
Primary outcome measure(s)
Module 1 and 2: Parts A and B: Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interests (AESIs) — From Day 1 up to approximately 3 years Part A: To assess the safety and tolerability and to determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) of AZD0516 as monotherapy and in combination with anti-cancer agents.
Part B: To assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents.
Module 1 and 2: Part A: Number of participants with Dose Limiting Toxicities (DLTs) — From Day 1 up to end of DLT period (approximately 21 days) To assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents.
Module 1: Parts B and C and Module 2: Part B: Percentage of participants with Prostate-Specific Antigen (PSA) 50 response rate — Up to approximately 2 years The PSA50 response rate is defined as the percentage of participants achieving ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result.
Trial sites (52)
Facility
City
Region
Status
Research Site
Fayetteville
Arkansas
Recruiting
Research Site
Los Angeles
California
Recruiting
Research Site
Towson
Maryland
Suspended
Research Site
Boston
Massachusetts
Recruiting
Research Site
Ann Arbor
Michigan
Recruiting
Research Site
Detroit
Michigan
Recruiting
Research Site
Buffalo
New York
Suspended
Research Site
New York
New York
Recruiting
Research Site
Providence
Rhode Island
Recruiting
Research Site
Myrtle Beach
South Carolina
Recruiting
Research Site
Houston
Texas
Recruiting
Research Site
Barretos
Brazil
Not Yet Recruiting
Research Site
Porto Alegre
Brazil
Not Yet Recruiting
Research Site
São Paulo
Brazil
Not Yet Recruiting
Research Site
Changsha
China
Not Yet Recruiting
Research Site
Chengdu
China
Not Yet Recruiting
Research Site
Wuhan
China
Not Yet Recruiting
Research Site
Lyon
France
Withdrawn
Research Site
Montpellier
France
Withdrawn
Research Site
Saint-Herblain
France
Withdrawn
Research Site
Suresnes
France
Withdrawn
Research Site
Villejuif
France
Withdrawn
Research Site
Milan
Italy
Not Yet Recruiting
Research Site
Milan
Italy
Not Yet Recruiting
Research Site
Milan
Italy
Not Yet Recruiting
Research Site
Naples
Italy
Not Yet Recruiting
Research Site
Roma
Italy
Not Yet Recruiting
Research Site
Rozzano
Italy
Not Yet Recruiting
Research Site
Chūōku
Japan
Recruiting
Research Site
Kashiwa
Japan
Not Yet Recruiting
Research Site
Kōtoku
Japan
Recruiting
Research Site
Koszalin
Poland
Not Yet Recruiting
Research Site
Piotrkow Trybunalski
Poland
Not Yet Recruiting
Research Site
Przemyśl
Poland
Not Yet Recruiting
Research Site
Seoul
South Korea
Not Yet Recruiting
Research Site
Seoul
South Korea
Recruiting
Research Site
Seoul
South Korea
Recruiting
Research Site
Seoul
South Korea
Recruiting
Research Site
Seoul
South Korea
Not Yet Recruiting
Research Site
Barcelona
Spain
Recruiting
+ 12 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.