First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer

Part of paid clinical trials in Orlando, Florida.

Sponsor
AstraZeneca
Study ID
NCT07529717
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD8359 — DRUG
    AZD8359 Monotherapy Administration route 1
  • AZD8359 — DRUG
    AZD8359 Monotherapy Administration route 2
  • AZD8359 — DRUG
    AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)
  • AZD8359 — DRUG
    AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)

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 AZD8359. The study is split into different modules which will look at AZD8359 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels and dosing schedules of AZD8359 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 AZD8359 doses in a larger group of participants (dose expansion).

Key Dates

Start date
May 18, 2026
Status verified
May 2026
Primary completion
Nov 17, 2027
Completion
Nov 17, 2027

Study Design

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

Arms

  • Experimental: Module 1 - Part A (Dose Escalation)
  • Experimental: Module 2 - Part A (Dose Escalation)
  • Experimental: Module 1/2 - Part B1 (Dose Expansion)
  • Experimental: Module 1/2 - Part B2 (Dose Expansion)

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 (4)

FacilityCityStateZIPSite coordinators
Research SiteOrlandoFlorida32806-
Research SiteEast BrunswickNew Jersey08816-
Research SiteHackensackNew Jersey07601-
Research SiteProvidenceRhode Island02903-

Find similar trials in Orlando, FL

By research site
Research Site· Orlando, FLResearch Site· East Brunswick, NJResearch Site· Hackensack, NJResearch Site· Providence, RI

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