Clinical Trial

Clinical Trial of PM54 in Advanced Solid Tumors Patients.

Recruiting Phase 1
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-04-21; most recent amendment 2025-09-19.
Trial Details
NCT Number NCT05841563
Lead Sponsor PharmaMar
Conditions Advanced Solid Tumor
Enrollment 125 participants
Start Date 2023-04-28
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-24