NCT05733351

Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer

Multiple-Arm Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of XmAb20717 in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial tests the safety and effectiveness of vudalimab (XmAb20717) in combination with standard of care treatment abiraterone, enzalutamide, or abiraterone plus docetaxel in treating patients with castration sensitive prostate cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as vudalimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding vudalimab to standard of care treatments may be effective in treating metastatic castration sensitive prostate cancer.

Detailed description

PRIMARY OBJECTIVE: I. To determine the safety and tolerability of vudalimab (XmAb20717) in combination with standard of care treatment in subjects with metastatic castration sensitive prostate cancer (mCSPC) as assessed by frequency and intensity of adverse events. SECONDARY OBJECTIVE: I. To assess the preliminary antitumor activity of vudalimab (XmAb20717) with standard of care treatment. TERTIARY/EXPLORATORY OBJECTIVE: I. To identify factors that may be indicative of response to vudalimab (XmAb20717) in combination with standard of care treatments. OUTLINE: Patients are assigned to 1 of 3 cohorts. COHORT A: Patients receive vudalimab intravenously (IV) on days 1 and 15 plus abiraterone orally (PO) once daily (QD) of 4-week cycles on study. Patients also undergo prostate-specific membrane antigen (PSMA) positron emission tomography (PET) and fludeoxyglucose (FDG) PET scans during screening. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) scans, bone scans, and blood sample collection throughout the study. COHORT B: Patients receive vudalimab IV on days 1 and 15 plus enzalutamide PO QD of 4-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample collection throughout the study. COHORT C: Patients receive vudalimab IV on days 1 and 15, docetaxel IV on days 1 and 22 plus abiraterone PO QD of 6-week cycles on study. Patients also undergo PSMA PET and FDG PET scans during screening. Patients also undergo CT and/or MRI scans, bone scans, and blood sample collection throughout the study.

Conditions

• Castration-Sensitive Prostate Carcinoma
• Metastatic Prostate Adenocarcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Abiraterone	Given PO
PROCEDURE	Biospecimen Collection	Undergo blood and stool sample collection
PROCEDURE	Bone Scan	Undergo bone scan
PROCEDURE	Computed Tomography	Undergo CT
DRUG	Docetaxel	Given IV
DRUG	Enzalutamide	Given PO
PROCEDURE	FDG-Positron Emission Tomography	Undergo FDG PET
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	PSMA PET Scan	Undergo PSMA PET
DRUG	Vudalimab	Given IV

Timeline

• Start date: 2023-08-03
• Primary completion: 2025-06-12
• Completion: 2025-06-12
• First posted: 2023-02-17
• Last updated: 2025-09-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study