Study of AZD0754 for Treating Metastatic Prostate Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT06267729

Provider View

This clinical trial is testing a new CAR T-cell therapy called AZD0754 to see if it is safe and effective for patients with metastatic prostate cancer. The study will also look at how the treatment behaves in the body and how it can be produced for use in patients.

Patient Parameters

Program Overview

This study is the first to test AZD0754, a CAR T-cell therapy, in humans. It involves multiple centers and is open to participants with metastatic prostate cancer. The treatment is given through an IV and aims to evaluate its safety, how it moves and works in the body, its early effectiveness, and how feasible it is to produce for patients.

Description

This trial is designed to test a new treatment called AZD0754, which is a type of CAR T-cell therapy. This therapy uses a patient's own immune cells, which are modified in a lab to better fight cancer, and then returned to the patient's body. The study will take place in multiple locations and is open to patients with metastatic prostate cancer. The main goals are to see if the treatment is safe, how it behaves in the body, and if it shows any early signs of effectiveness. Researchers will also assess how practical it is to produce this treatment for patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have metastatic prostate cancer confirmed by lab tests, without certain rare features.
  • Cancer must be resistant to hormone therapy and show signs of progression.
  • Must have received certain previous treatments for prostate cancer or be unable to take them.
  • For those with specific genetic mutations, must have tried certain other treatments.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must have a life expectancy of more than 12 weeks.
  • Must have adequate organ and bone marrow function.
  • Must agree to provide tumor samples for research purposes.

Exclusion Criteria

  • Weigh less than 39 kg.
  • Have another active cancer, except for certain treated skin cancers.
  • Have known brain metastases.
  • Have had a solid organ transplant.
  • Have certain autoimmune or inflammatory disorders, unless well-controlled.
  • Have had a stroke, brain bleed, or seizure in the past 6 months.
  • Have certain heart conditions or uncontrolled illnesses.
  • Have active epilepsy or certain persistent side effects from previous cancer treatments.
  • Test positive for HIV or have active hepatitis C or B infections.
  • Have received certain treatments or medications recently, including major surgery or live vaccines.
  • Have a known allergy to AZD0754 or its ingredients.

Locations

FACILITYZIPCITYSTATE
Research Site91010DuarteCalifornia
Research Site91010DuarteCalifornia
Research Site33612TampaFlorida
Research Site30322AtlantaGeorgia
Research Site66205WestwoodKansas
Research Site63110Saint LouisMissouri
Research Site07601HackensackNew Jersey
Research Site10032New YorkNew York
Research Site10065New YorkNew York
Research Site19104PhiladelphiaPennsylvania

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