Drugs / PM54
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05841563 | Apr 2023 → Dec 2026 expected | neoplasm | PharmaMar | Recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07839819 | Nov 2026 → Sep 2029 expected | neoplasm | PharmaMar | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07644039 | May 2026 → Apr 2029 expected | cancer | PharmaMar | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-09-23 | PharmaMar | Regulatory PharmaMar receives FDA clearance for the PM54 platform trial STARFISH-54 to accelerate combination development across solid tumors pharmamar.com ↗
PharmaMar (MSE: PHM) has announced that the American Food and Drug Administration (FDA) has provided clearance for platform trial STARFISH-54 for PM54 to evaluate its activity in various solid tumors in combination with other therapies. |
| 2026-04-16 | PharmaMar | Results PharmaMar presents its scientific publications at the Annual Meeting of the American Association for Cancer Research (AACR) pharmamar.com ↗
In mouse models, PM54 significantly reduced tumor growth, and combination with 5-FU or cisplatin induces greater tumor growth inhibition than that achieved with either 5-FU or cisplatin alone. |
| 2025-12-18 | PharmaMar | Regulatory The FDA approves PharmaMar’s Investigational NewDrug (IND) application for the combination of PM54 with immunotherapy in solid tumors pharmamar.com ↗
PharmaMar (MSE:PHM) has received from the U.S Food and Drug Administration (FDA) an investigational new drug (IND) approval, to start a Phase 1/2 multicenter clinical trial for the combination of PM54 with immunotherapy for the treatment of advanced stage solid tumors. |
| 2025-04-28 | PharmaMar | Results PharmaMar presents eleven scientific publications at the Annual Meeting of the American Association for Cancer Research (AACR) pharmamar.com ↗
On this occasion, the Company is presenting eleven new studies with results on the activity of its compounds: lurbinectedin (Zepzelca®), ecubectedin, PM54, PM534, and trabectedin (Yondelis®). |
All press releases naming this drug 6 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PM54 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05841563 ↗ |
| Route | Intravenous | “Route of administration: Intravenous infusion” NCT05841563 ↗ |