NCT06085729

Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To find the best dose of ADI-PEG20 that can be given in combination with carboplatin and cabazitaxel to patients with AVPC.

Detailed description

Primary Objective: To select an optimal dose of ADI-PEG 20 to combine with carboplatin+cabazitaxel Secondary Objectives: To determine the effects of ADI-PEG 20+carboplatin+cabazitaxel on 1. Serum levels of arginine, citrulline and circulating anti-ADI-PEG 20 antibodies 2. Intratumoral levels of arginine by ion chromatography/mass spectrometry 3. Expression of ASS1 by immunohistochemistry 4. Expression of genes involved in arginine metabolism and downstream pathways 5. Immune checkpoint expression and immune-cell populations in the AVPC tumor microenvironment 6. Safety and tolerability 7. Overall response 8. Progression-free survival 9. Overall survival

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	ADI-PEG 20	Given by Injection
DRUG	Cabazitaxel	Given by IV (vein)
DRUG	Carboplatin	Given by IV (vein)

Timeline

• Start date: 2024-02-29
• Primary completion: 2027-09-02
• Completion: 2027-12-31
• First posted: 2023-10-17
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study