NCT05841563

Clinical Trial of PM54 in Advanced Solid Tumors Patients.

Phase I/Ib, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM54 Administered Intravenously to Patients With Selected Advanced Solid Tumors.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: PharmaMar · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The first part of the study (phase Ia - dose escalation) will evaluate the safety and tolerability and identify the dose-limiting toxicities (DLTs) of PM54. The second part of the study (phase Ib - safety run-in and expansion) will be to reassess the maximum tolerated dose (MTD) defined in the Phase Ia stage in a framework of more extensive premedication, and to evaluate the antitumor activity of PM54 according to the RECIST v.1.1 (or mRECIST v.1.1 in case of MPM) and/or serum markers as appropriate, in patients with selected advanced solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	PM54	PM54 powder for concentrate for solution for infusion (3 mg/vial) is a sterile, preservative-free, lyophilized white to yellowish cake in a single-dose vial for reconstitution prior to intravenous infusion. Each vial contains 3 mg PM54. Route of administration: Intravenous infusion

Timeline

• Start date: 2023-04-28
• Primary completion: 2026-12-30
• Completion: 2027-04-30
• First posted: 2023-05-03
• Last updated: 2025-09-24

Locations

3 sites across 3 countries: United States, Belgium, Spain

Regulatory

• FDA-regulated drug study