Clinical Trial of PM54 in Advanced Solid Tumors Patients.

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT05841563

Run by

PharmaMar

People needed

125

Starts

2023-04-28

Expected to finish

2027-04-30

Last updated by the study team

2025-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily signed and dated written informed consent, obtained prior to any specific study procedure.
• Age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
• Phase Ia (dose escalation) stage: patients must have:
• Pathologically confirmed diagnosis of advanced solid tumors for whom no standard therapy exists:
• 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.
• Note: patients with measurable or non-measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1 (or mRECIST v.1.1 in case of MPM) are eligible during this stage.
• No more than three prior lines of chemotherapy.
• Phase Ib (safety run-in and expansion) stage: patients must have:
• Pathologically confirmed diagnosis of one of the following:
• 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
• 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).
• Progressive disease after last therapy at study entry.

You may not qualify if…

• For both stages:
• Concomitant diseases/conditions:
• Increased cardiac risk:
• 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.
• Active infection requiring systemic treatment.
• 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.
• 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).
• 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).
• Patients with carcinomatous meningitis.
• Prior bone marrow or stem cell transplantation.
• Prior treatment with trabectedin, lurbinectedin, or ecubectedin (PM14).
• Use of (strong or moderate) inhibitors or strong inducers of CYP3A4 activity within two weeks prior to the first infusion of PM54.
• Known hypersensitivity to any of the components of the drug product.
• Limitation of the patient's ability to comply with the treatment or to follow the protocol procedures.
• 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).

Where it is running

• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States (enrolling)
• Institut Jules Bordet — Anderlecht, Belgium (enrolling)
• HM Universitario Sanchinarro — Madrid, M, Spain (enrolling)

Full record on ClinicalTrials.gov

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