A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer

Part of paid clinical trials in Orlando, Florida.

Sponsor
AstraZeneca
Study ID
NCT07192614
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD6621 — DRUG
    A T Cell-engaging Antibody that targets STEAP2, CD3, and CD8

Study Details

This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD6621. The study is split into different modules which will look at AZD6621 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels of AZD6621 to determine which doses are the best in terms of safety and side effects (dose escalation), and Part B will further test at least two AZD6621 doses in a larger group of participants (dose expansion).

Key Dates

Start date
Sep 30, 2025
Status verified
Jun 2026
Primary completion
Mar 29, 2029
Completion
Mar 29, 2029

Study Design

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

Arms

  • Experimental: Module 1 - Part A (Dose Escalation)
    AZD6621 Monotherapy - Administration route 1
  • Experimental: Module 2 - Part A (Dose Escalation)
    AZD6621 Monotherapy - Administration route 2
  • Experimental: Module 1/2 - Part B1 (Dose Expansion)
    AZD6621 Monotherapy - Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)
  • Experimental: Module 1/2 - Part B2 (Dose Expansion)
    AZD6621 Monotherapy - Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)

Primary Outcome Measure

Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE) [ Time Frame: From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteOrlandoFlorida32806-
Research SiteTampaFlorida33612-
Research SiteBostonMassachusetts02114-
Research SiteGrand RapidsMichigan49546-
Research SiteCommackNew York11725-
Research SiteProvidenceRhode Island02903-

Find similar trials in Orlando, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Research Site· Orlando, FLResearch Site· Tampa, FLResearch Site· Boston, MAResearch Site· Grand Rapids, MIResearch Site· Commack, NYResearch Site· Providence, RI

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