NCT05733351

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

Terminated Phase 1 Last updated 15 September 2025

What this trial tests

Phase 1 trial testing Abiraterone in Castration-Sensitive Prostate Carcinoma in 4 participants. Terminated before completion.

Timeline

3 August 2023

Primary endpoint
12 June 2025

12 June 2025

Quick facts

Lead sponsor	Emory University
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	3 August 2023
Primary completion	12 June 2025
Estimated completion	12 June 2025
Sites	2 locations across United States

Drugs / interventions tested

• Abiraterone (ABIRATERONE) — full drug profile →
• Biospecimen Collection
• Bone Scan — full drug profile →
• Computed Tomography
• Docetaxel (Docetaxel) — full drug profile →
• Enzalutamide (enzalutamide) — full drug profile →
• FDG-Positron Emission Tomography
• Magnetic Resonance Imaging
• PSMA PET Scan
• Vudalimab

Conditions studied

• Castration-Sensitive Prostate Carcinoma — all drugs for Castration-Sensitive Prostate Carcinoma →
• Metastatic Prostate Adenocarcinoma — all drugs for Metastatic Prostate Adenocarcinoma →
• Stage IVB Prostate Cancer AJCC v8 — all drugs for Stage IVB Prostate Cancer AJCC v8 →

Sponsor

Emory University

Who can join

18 and older, male only, with Castration-Sensitive Prostate Carcinoma or Metastatic Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Programmed death receptor (PD-)1/PD-ligand (L)1 in urological cancers : the "all-around warrior" in immunotherapy.
   Liu Q, Guan Y, Li S. · · 2024 · cited 50× · PMID 39223527 · DOI 10.1186/s12943-024-02095-8
2. T-Cell redirecting bispecific antibodies: a review of a novel class of immuno-oncology for advanced prostate cancer.
   Palecki J, Bhasin A, Bernstein A, Mille PJ, et al · · 2024 · cited 25× · PMID 38801069 · DOI 10.1080/15384047.2024.2356820
3. Clinical Progresses and Challenges of Bispecific Antibodies for the Treatment of Solid Tumors.
   Gu Y, Zhao Q. · · 2024 · cited 16× · PMID 39172329 · DOI 10.1007/s40291-024-00734-w
4. Overcoming drug resistance in castrate-resistant prostate cancer: current mechanisms and emerging therapeutic approaches.
   Khorasanchi A, Hong F, Yang Y, Singer EA, et al · · 2025 · cited 12× · PMID 40051495 · DOI 10.20517/cdr.2024.173
5. Bispecific antibodies as powerful immunotherapeutic agents for urological cancers: Recent innovations based on preclinical and clinical evidence.
   Hushmandi K, Einollahi B, Lee EHC, Sakaizawa R, et al · · 2025 · cited 7× · PMID 39990653 · DOI 10.7150/ijbs.96155
6. New frontiers in prostate cancer treatment from systemic therapy to targeted therapy.
   Nouruzi S, Kobelev M, Tabrizian N, Gleave M, et al · · 2025 · cited 3× · PMID 40759791 · DOI 10.1038/s44321-025-00282-8
7. Immunotherapeutic Strategies for Prostate Cancer: A Comprehensive Review.
   Flores-Islas AK, Rico-Fuentes C, Sierra-Díaz E, García-Chagollán M, et al · · 2026 · PMID 41595174 · DOI 10.3390/cancers18020255