NCT05229588

Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations

A Phase II Pilot Clinical Trial of Lurbinectedin (Zepzelca™ PM01183) in Patients With Gastrointestinal Malignancies With DNA Repair Mutations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: HonorHealth Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to evaluate the activity and safety of lurbinectedin in adult patients with advanced Gastrointestinal Malignancies with DNA repair mutations.

Conditions

• Gastrointestinal Malignancies

Interventions

Type	Name	Description
DRUG	Lurbinectedin 4 MG Injection [Zepzelca]	Lurbinectedin will be administered with a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride). Lurbinectedin will be administered intravenously through peripheral or central lines at a dose of 3.2 mg/m2 at a fixed infusion rate.

Timeline

• Start date: 2022-06-14
• Primary completion: 2025-08-04
• Completion: 2025-08-04
• First posted: 2022-02-08
• Last updated: 2025-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study