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First received: March 31, 2023

Clinical Trial: Clinical Trial of PM54 in Advanced Solid Tumors Patients.

Study Status: Completed

Recruit Status: RECRUITING

Condition: Advanced Solid Tumor

Study Type: INTERVENTIONAL


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

Brief 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 - expansion) will be to evaluate the antitumor activity of PM54 in terms of clinical benefit (response or stable disease [SD] ?4 months associated with tumor shrinkage), according to the RECIST v.1.1 and/or serum markers as appropriate, in patients with selected advanced solid tumors.

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