Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer

Part of paid clinical trials in Encino, California.

Sponsor
AstraZeneca
Study ID
NCT07590934
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD2265 (FPI-2265) — DRUG
    AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
  • AZD9574 — DRUG
    AZD9574 will be administered orally.
  • Docetaxel — DRUG
    Docetaxel will be administered as an IV infusion.
  • AZD2287 (Imaging agent) — DRUG
    AZD2287 will be administered as an IV injection.

Study Details

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of multiple anti-cancer agents in participants with metastatic prostate cancer.

Key Dates

Start date
May 14, 2026
Status verified
May 2026
Primary completion
Sep 5, 2029
Completion
Sep 5, 2029

Study Design

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

Arms

  • Experimental: Sub study 1 Part A (SS1A): escalating dose levels of AZD9574 in combination with AZD2265 (FPI-2265)
    Participants will receive escalating dose levels of AZD9574 once daily in combination with AZD2265 (FPI-2265) once every 6 weeks (Q6W).
  • Experimental: Sub study 1 Part B (SS1B): selected dose of AZD9574 in combination with AZD2265 (FPI-2265)
    Participants will receive AZD9574 chosen from the DE phase once daily in combination with AZD2265 (FPI-2265) Q6W.
  • Experimental: SS1B: AZD2265 (FPI-2265) monotherapy
    Participants will receive AZD2265 (FPI-2265) monotherapy Q6W.
  • Active Comparator: SS1B: Docetaxel
    Participants will receive docetaxel as a standard of care (SoC) once every 3 weeks (Q3W).

Primary Outcome Measure

Part A: Number of participants with treatment-emergent adverse events (TEAEs)including serious adverse events (SAEs), treatment-related AEs (TRAEs) and adverse events of special interests (AESIs) [ Time Frame: Up to approximately 1 year after last dose ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Research SiteEncinoCalifornia91436-
Research SiteSouth PasadenaCalifornia91030-
Research SiteMiamiFlorida33165-
Research SiteTampaFlorida33612-
Research SiteMinneapolisMinnesota55455-
Research SiteOmahaNebraska68130-
Research SiteNew YorkNew York10065-
Research SitePortlandOregon97239-
Research SiteHoustonTexas77030-

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