๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-09-19

Clinical Trial of PM54 in Advanced Solid Tumors Patients. (NCT05841563)

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

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: PharmaMar

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: South Texas Accelerated Research Therapeutics โ€” San Antonio, Texas

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (3 Sites)

  • South Texas Accelerated Research Therapeutics โ€” San Antonio, Texas
  • Institut Jules Bordet โ€” Anderlecht,
  • HM Universitario Sanchinarro โ€” Madrid, M

๐Ÿ“ž Contact the Study Coordinator

Phone: + 34 91 846 6077

Email: cmfernandez@pharmamar.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—