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

  • Protocol Number: 202510155
  • Principal Investigator: Trikalinos, Nikolaos
  • Cancer Types: Early Phase

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
[email protected]

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 – 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 Interventions

Drug: PM54