NCT06267729

Study of AZD0754 in Participants With Metastatic Prostate Cancer

A Phase I/II Open Label Study to Evaluate the Safety, Cellular Kinetics, and Efficacy of AZD0754, a Chimeric Antigen Receptor (CAR) T-cell Therapy Directed Against STEAP2, in Adult Participants With Metastatic Prostate Cancer: APOLLO

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a first-time in human, multi-center, open label, Phase I/II study of AZD0754 autologous CAR T-cell therapy administered intravenously to participants with metastatic prostate cancer. The study is intended to assess the safety, cellular kinetics, pharmacodynamics, preliminary efficacy, and feasibility of manufacturing AZD0754 for patients with metastatic prostate cancer.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	AZD0754	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.
BIOLOGICAL	AZD2287	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.

Timeline

• Start date: 2024-03-12
• Primary completion: 2026-11-24
• Completion: 2026-11-24
• First posted: 2024-02-20
• Last updated: 2026-02-23

Locations

15 sites across 3 countries: United States, Australia, Spain

Regulatory

• FDA-regulated drug study