Study of AZD0754 in Participants With Metastatic Prostate Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT06267729
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

  • AZD0754 — BIOLOGICAL
    Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce AZD0754. During AZD0754 production, subjects may receive bridging therapy for disease control. Upon successful generation of AZD0754 product, subjects will receive treatment with AZD0754 therapy. Study treatment will include lymphodepleting chemotherapy. After lymphodepleting chemotherapy AZD0754 is administered intravenously and patients will be required to stay at the hospital for a protocol specified monitoring period.
  • AZD2287 — BIOLOGICAL
    This is an Optional arm of the study, which subjects will separately consent to if they would like to participate. Subjects will receive doses of a radioactive imaging agent called AZD2287 followed by SPECT/CT imaging scans at two time points.

Study Details

The purpose of this study is to evaluate the safety, tolerability, and antitumour activity of AZD0754 CAR T-cell therapy in participants with metastatic prostate cancer.

Key Dates

Start date
Mar 12, 2024
Status verified
Feb 2026
Primary completion
Nov 24, 2026
Completion
Nov 24, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD0754
    AZD0754 monotherapy for treatment of participants with metastatic prostate cancer.
  • Experimental: AZD2287
    AZD2287 is a novel imaging agent for STEAP2

Primary Outcome Measure

Incidence of participants with Dose-limiting Toxicity (DLTs)/DLT-like events, Adverse Events (AEs), including Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs). [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteTampaFlorida33612-
Research SiteAtlantaGeorgia30322-
Research SiteWestwoodKansas66205-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02215-
Research SiteSt LouisMissouri63110-
Research SiteHackensackNew Jersey07601-
Research SiteNew YorkNew York10032-
Research SiteNew YorkNew York10065-
Research SitePhiladelphiaPennsylvania19104-
Research SiteDallasTexas75235-
Research SiteHoustonTexas77030-

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