A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Metastatic Prostate Cancer

Status: Recruiting
Location: See all (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:

• 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:

‣ 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).

⁃ 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).

⁃ 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.

Locations
United States
Arkansas
Research Site
NOT_YET_RECRUITING
Fayetteville
California
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NOT_YET_RECRUITING
Los Angeles
Massachusetts
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NOT_YET_RECRUITING
Boston
Michigan
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NOT_YET_RECRUITING
Ann Arbor
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NOT_YET_RECRUITING
Detroit
New York
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NOT_YET_RECRUITING
Buffalo
Research Site
NOT_YET_RECRUITING
New York
Rhode Island
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NOT_YET_RECRUITING
Providence
South Carolina
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RECRUITING
Myrtle Beach
Texas
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NOT_YET_RECRUITING
Houston
Other Locations
Brazil
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NOT_YET_RECRUITING
Barretos
Research Site
NOT_YET_RECRUITING
Porto Alegre
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NOT_YET_RECRUITING
São Paulo
China
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NOT_YET_RECRUITING
Changsha
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NOT_YET_RECRUITING
Chengdu
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NOT_YET_RECRUITING
Wuhan
France
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NOT_YET_RECRUITING
Lyon
Research Site
NOT_YET_RECRUITING
Montpellier
Research Site
NOT_YET_RECRUITING
Saint-herblain
Research Site
NOT_YET_RECRUITING
Suresnes
Research Site
NOT_YET_RECRUITING
Villejuif
Italy
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Milan
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NOT_YET_RECRUITING
Napoli
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NOT_YET_RECRUITING
Roma
Research Site
NOT_YET_RECRUITING
Rozzano
Japan
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NOT_YET_RECRUITING
Chūōku
Research Site
NOT_YET_RECRUITING
Kashiwa
Research Site
NOT_YET_RECRUITING
Kōtoku
Poland
Research Site
NOT_YET_RECRUITING
Koszalin
Research Site
NOT_YET_RECRUITING
Piotrkow Trybunalski
Research Site
NOT_YET_RECRUITING
Przemyśl
Republic of Korea
Research Site
NOT_YET_RECRUITING
Seoul
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NOT_YET_RECRUITING
Seoul
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NOT_YET_RECRUITING
Seoul
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NOT_YET_RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Seoul
Spain
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Research Site
NOT_YET_RECRUITING
Madrid
Research Site
NOT_YET_RECRUITING
Pamplona
Research Site
NOT_YET_RECRUITING
Santander
Research Site
NOT_YET_RECRUITING
Valencia
United Kingdom
Research Site
NOT_YET_RECRUITING
Cambridge
Research Site
NOT_YET_RECRUITING
London
Research Site
NOT_YET_RECRUITING
London
Research Site
NOT_YET_RECRUITING
Plymouth
Research Site
NOT_YET_RECRUITING
Sutton
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2029-01-18
Participants
Target number of participants: 177
Treatments
Experimental: Arm 1: AZD0516 monotherapy
Participants with mCRPC will receive AZD0516 monotherapy.
Experimental: Arm 2: AZD0516 + AZD9574
Participants with mCRPC will receive AZD0516 in combination with AZD9574.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Parexel

This content was sourced from clinicaltrials.gov

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