Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
AstraZeneca
Study ID
NCT07181161
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD0516 — DRUG
    AZD0516 will be administered via intravenous infusion.
  • AZD9574 — DRUG
    AZD9574 will be administered orally.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
May 2026
Primary completion
Jan 18, 2029
Completion
Jan 18, 2029

Study Design

Enrollment
177 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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) [ Time Frame: From Day 1 up to approximately 3 years ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Research SiteFayettevilleArkansas72703-
Research SiteLos AngelesCalifornia90095-
Research SiteTowsonMaryland21204-
Research SiteBostonMassachusetts02114-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48201-
Research SiteBuffaloNew York14263-
Research SiteNew YorkNew York10065-
Research SiteProvidenceRhode Island02906-
Research SiteMyrtle BeachSouth Carolina29572-
Research SiteHoustonTexas77030-

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Research Site· Fayetteville, ARResearch Site· Los Angeles, CAResearch Site· Towson, MDResearch Site· Boston, MAResearch Site· Ann Arbor, MIResearch Site· Detroit, MI

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