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PM54 for Advanced Solid Tumors

This study is testing a new drug called PM54 for people with advanced solid tumors, which are cancers that have spread and for which standard treatments are no longer effective. The main goals are to find a safe dose of PM54 and to see if it causes side effects. Researchers will also look at how well PM54 works against the cancer. You might be able to join if you are at least 18 years old, have a good general health status (ECOG performance status ≤1), and have advanced solid tumors. The study is currently recruiting participants.

Study design
This is an interventional study planning to enroll 125 participants. It has two parts: Phase 1a to find a safe dose, and Phase 1b to confirm the dose and evaluate the drug's effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured up to the end of the first treatment cycle, which is 21 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05841563

Clinical Trial of PM54 in Advanced Solid Tumors Patients.

Recruiting
PHASE1Ages 18+InterventionalTreatment
PharmaMar
~125 participants
Updated 2025-09-24 on ClinicalTrials.gov
What's tested:PM54

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a (dose escalation) and Phase1b (safety run-in): Dose-limiting toxicities (DLTs)
Measured over Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
+11 more outcomes measured

Conditions

Advanced Solid Tumor

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NCT05841563

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • HM Universitario Sanchinarro

    Madrid, M, Spainno site contact published

    Recruiting

  • Institut Jules Bordet

    Anderlecht, Belgiumno site contact published

    Recruiting

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Cristian M Fernández, M.D.
[email protected]
+ 34 91 846 6077
Email the study team

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Eligibility criteria

Inclusion

Genitourinary tract tumors: urothelial carcinoma, clear cell renal carcinoma and prostate adenocarcinoma.
Cutaneous melanoma.
Gastrointestinal: esophageal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, and poorly differentiated (grade 3) gastroenteropancreatic Neuroendocrine Carcinoma (NEC )with Ki67 index \>55%.
Lung: non-small cell lung cancer (NSCLC) and Small Cell Lung Cancer (SCLC).
Gynecological tumors: epithelial ovarian carcinoma (including primary peritoneal disease and/or fallopian tube carcinomas), endometrial adenocarcinoma and carcinoma of cervix.
Breast: ductal or lobular.
Sarcoma: liposarcoma, leiomyosarcoma, synovial sarcoma and Ewing sarcoma.
Deleterious germline BRCA1/2 mutation tumors.
Other: MPM, extrapulmonary small cell carcinoma, adrenocortical carcinoma.
Extrapulmonary small cell carcinoma) or poorly differentiated grade 3 gastroenteropancreatic NEC with Ki67 index ≥55%.
Cutaneous melanoma.
Malignant pleural mesothelioma (MPM).
Endometrial adenocarcinoma (Note: carcinosarcomas are not allowed).
Synovial sarcoma 2. Measurable disease according to the RECIST v.1.1 (or mRECIST v.1.1 in case of MPM) and/or evaluable disease byserum markers in case of prostate and ovarian cancer (according to the Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and the Gynecologic Cancer Intergroup (GCIG) specific criteria, respectively). 3. Progressive disease after last therapy at study entry. 4. Patients must have received standard treatments:
Extrapulomnary small cell carcinoma/ gastroenteropancreatic NEC: no more than two prior lines of chemotherapy.
Cutaneous melanoma:
Malignant pleural mesothelioma (MPM): no more than two prior lines of therapy; one of them should be a platinum containing line. Patients with non-epithelioid MPM should have received a prior immunotherapy line.
Endometrial adenocarcinoma: no more than two prior lines of chemotherapy for metastatic disease. In addition, regardless of setting, patients must have received one prior platinum-containing regimen.
Synovial sarcoma: at least one but no more than two prior lines of chemotherapy. 6. Recovery to grade ≤1 from drug-related AEs of previous treatments, excluding grade 2 alopecia, according to the NCI-CTCAE v.5. 7. Laboratory values within seven days prior to first infusion:
Albumin infusion to increase the blood level in order to fulfill the inclusion criterion is strictly forbidden.

Exclusion

Uncontrolled arterial hypertension despite optimal management (≥160/100 mmHg).
Presence of clinically relevant valvular disease.
History of long QT syndrome.
Corrected QT interval (QTcF, Fridericia correction) ≥450 ms on screening ECG.
History of ischemic heart disease, including myocardial infarction, unstable angina, coronary arteriography or cardiac stress testing with findings consistent with coronary occlusion or infarction ≤6 months prior to study entry.
History of heart failure or left ventricular dysfunction (left ventricular ejection fraction \[LVEF\] ≤50%) by multiple-gated acquisition scan (MUGA) or echocardiography (ECHO).
Clinically relevant ECG abnormalities, including any of the following: right bundle branch block with left anterior hemiblock, second (Mobitz II) or third degree atrioventricular block.
Symptomatic arrhythmia.
Concomitant medication with risk of inducing torsades de pointes, which cannot be discontinued or switched to an alternative drug prior to start PM54 dosing.
Use of a cardiac pacemaker. 2. Active infection requiring systemic treatment. 3. Known human immunodeficiency virus (HIV) or known chronic active hepatitis. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR. 4. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study (e.g., COVID-19). 2. Symptomatic, steroid-requiring, and progressing central nervous system (CNS) disease. Exceptions will be made for patients who have completed radiotherapy at least four weeks prior to inclusion (asymptomatic patients taking steroids in the process of already being tapered within two weeks prior to inclusion). 3. Patients with carcinomatous meningitis. 4. Prior bone marrow or stem cell transplantation. 5. Prior treatment with trabectedin, lurbinectedin, or ecubectedin (PM14). 6. Use of (strong or moderate) inhibitors or strong inducers of CYP3A4 activity within two weeks prior to the first infusion of PM54. 7. Known hypersensitivity to any of the components of the drug product. 8. Limitation of the patient's ability to comply with the treatment or to follow the protocol procedures. 9. Women who are pregnant or breast feeding and fertile patients (men and women) who are not using a highly effective method of contraception (see inclusion criterion No. 9).

What this trial measures

  • Phase 1a (dose escalation) and Phase1b (safety run-in): Dose-limiting toxicities (DLTs)Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
  • Phase 1a (dose escalation) and Phase1b (safety run-in): Treatment-emergent Adverse Events (TEAEs)Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
  • Phase 1a (dose escalation) and Phase1b (safety run-in): Drug-related Adverse Events (AEs)Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
  • Phase 1a (dose escalation) and Phase1b (safety run-in): Drug-related deathsDay 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
  • Phase 1a (dose escalation) and Phase1b (safety run-in): Serious adverse events (SAEs)Screening up to end of first cycle of treatment (Cycle 1 is 21 days)
  • Phase 1a (dose escalation) and Phase1b (safety run-in): Drug-related delaysDay 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
  • Phase 1a (dose escalation) and Phase1b (safety run-in): Dose reductionsDay 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
  • Phase 1a (dose escalation) and Phase1b (safety run-in): Treatment discontinuationsDay 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
  • Phase 1a (dose escalation) and Phase1b (safety run-in): Maximum tolerated dose (MTD)Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)

    Lowest dose level explored during dose escalation in which one third (i.e., 33%) or more of evaluable patients develop a DLT in Cycle 1.

  • Phase 1a (dose escalation) and Phase1b (safety run-in): Recommended dose (RD)Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)

    Once the maximum tolerated dose (MTD) is reached, lower dose level will be confirmed as the RD if less than one third (i.e., 33%) of at least nine fully evaluable patients at that dose level develop DLT during Cycle 1.

  • Phase1b (safety run-in): Determination of RD with more extensive premedicationDay 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)

    A dose level will be confirmed as the RD with more extensive premedication if less than one third (i.e., 33%) of at least nine fully evaluable patients at that dose level develop DLT during Cycle 1.

  • Phase 1b (expansion): Antitumor activityEvery 6 weeks (± 1 week) in all patients with evaluable disease until Cycle 6. For patients continuing treatment after Cycle 6, assessments performed every 9 weeks (± 1 week) while on treatment, unless otherwise indicated (Up to 48 months)

    Antitumor activity, evaluated according to the RECIST v.1.1 (or mRECIST v.1.1 in case of MPM) and serum markers, as appropriate.