NCT05835609

PM534 Administered Intravenously to Patients With Advanced Solid Tumors

Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM534 Administered Intravenously to Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: PharmaMar · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goals of this trial are to identify the dose limiting toxicities, to determine the maximum tolerated dose and the recommended dose of PM534 in patients with advanced solid tumors. All Patients will receive PM534 via intravenous.

Detailed description

This is a prospective, open-label, dose-escalating phase I study in patients with advanced solid tumors. Patients will be included in cohorts of a minimum of three or six patients to receive PM534 at successively increasing dose levels.

Conditions

• Patients With Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	PM534	PM534 drug product is provided as a powder for concentrate for solution for infusion, is a sterile, preservative-free, lyophilized white cake in a single-dose vial for reconstitution prior to intravenous infusion.

Timeline

• Start date: 2022-12-23
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-04-28
• Last updated: 2025-08-22

Locations

3 sites across 1 country: Spain