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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