RecruitingPhase 2NCT05915442

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

Phase II Single Arm Study Testing SBRT, Adenosine Signaling Modulation (AB680, AB928), and Immune Checkpoint Inhibition (AB122) for Men With Hormone Sensitive Oligometastatic Prostate Cancer


Sponsor

Catherine Spina

Enrollment

23 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — GB1211 (which blocks adenosine, a molecule tumors use to avoid immune attack) and pembrolizumab (an immunotherapy) — in men with hormone-sensitive prostate cancer that has spread to a small number of sites (oligometastatic). **You may be eligible if...** - You are a man with confirmed prostate cancer (adenocarcinoma) - Your primary prostate tumor was treated with surgery and/or radiation - You have 1–3 new metastases (spread to bone or soft tissue) that developed after initial treatment - You are on hormone therapy (androgen deprivation therapy) **You may NOT be eligible if...** - Your cancer is castration-resistant (progressing despite very low testosterone) - You have more than 3 metastatic sites - You have active autoimmune disease - You have had prior immunotherapy for prostate cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQuemliclustat

100mg IV once every two weeks

DRUGEtrumadenant

150 mg orally (PO) once a day (QD)

DRUGZimberelimab

240 mg IV once every two weeks starting within 1 week of completing metastasis-directed SBRT

RADIATIONStereotactic Body Radiation Therapy

Standard of care metastasis-directed hypofractionated radiotherapy treatment starting 4 weeks (+/- 1 week) of starting Etrumadenant and Quemliclustat


Locations(1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05915442


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