drugset / Trial / NCT05915442

Adenosine Signaling Modulation and Immune Checkpoint Inhibition With Hormone Sensitive Oligometastatic Prostate Cancer

NCT05915442

Phase 2 Recruiting 23 enrolled Catherine Spina Arcus Biosciences, Inc. · collab
NaSequentialOpen-labelTreatment

Summary

This study will evaluate the safety and effectiveness of a combination of study drugs including zimberelimab, etrumadenant, and quemliclustat in combination with metastasis-directed irradiation in men with hormone sensitive oligometastatic prostate cancer. The study aims to test the hypothesis that targeted inhibition of the adenosine signaling axis (quemliclustat (CD73 antagonist) + etrumadenant (A2AR/A2BR antagonist)) and immune checkpoint inhibition (zimberelimab, α-PD-1) in combination with metastasis-directed stereotactic body radiation therapy (SBRT) will improve local control, progression-free survival (PFS), and hormone therapy-free survival and mitigate immunosuppressive changes to the tumor microenvironment (TME), compared to SBRT alone.

Timeline

Start
2023-07-01
Primary completion
2026-12-01
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Etrumadenant Small molecule 150 mg Oral
Subject Quemliclustat Small molecule 100 mg Intravenous
Subject Zimberelimab Monoclonal antibody 240 mg Intravenous