First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer
← catalyst calendarNCT07529717 · readout in 455 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
42estimated
Sites
8
Countries
Australia, South Korea, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-05-18 | actual | When the study began enrolling |
| Primary completion | 2027-11-17 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-11-17 | estimated | The whole study's end, after follow-up |
| First posted | 2026-04-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Metastatic Prostate Cancer
Interventions
- Drug: AZD8359
- Drug: AZD8359
- Drug: AZD8359
- Drug: AZD8359
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE)
measured From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years)
Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)
measured From first study dose to 21 OR 28 days post first dose based on schedule
PSA response rate (Part B only)
measured Up to 3 years
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