Actively Recruiting
Clinical Trial of PM54 in Advanced Solid Tumors Patients.
Led by PharmaMar · Updated on 2025-09-24
125
Participants Needed
3
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial of PM54 in Advanced Solid Tumors Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed and dated written informed consent before any study procedure
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- For Phase Ia: Diagnosis of advanced solid tumors with no standard therapy, including specified types such as genitourinary, melanoma, gastrointestinal, lung, gynecological, breast, sarcoma, BRCA1/2 mutation tumors, and others
- For Phase Ia: No more than three prior lines of chemotherapy
- For Phase Ib: Diagnosis of specified tumors including extrapulmonary small cell carcinoma, grade 3 gastroenteropancreatic NEC, melanoma, malignant pleural mesothelioma, endometrial adenocarcinoma (excluding carcinosarcomas), or synovial sarcoma
- For Phase Ib: Measurable or evaluable disease by RECIST v1.1 or serum markers as appropriate
- For Phase Ib: Progressive disease after last therapy
- For Phase Ib: Received specified prior standard treatments with limits on prior chemotherapy lines depending on tumor type
- Recovery to grade 1 or less from previous drug-related adverse events (excluding grade 2 alopecia)
- Laboratory values within 7 days before first infusion meeting specified thresholds for blood counts, liver and kidney function, and serum albumin
- Required washout periods from prior therapies ranging from 1 to 4 weeks depending on treatment type
- Evidence of non-childbearing status for women of childbearing potential and use of effective contraception by participants and partners
- Albumin infusion to raise blood level before study entry is forbidden
You will not qualify if you...
- Uncontrolled arterial hypertension (≥160/100 mmHg) despite treatment
- Clinically significant valvular heart disease
- History of long QT syndrome or corrected QT interval ≥450 ms
- Recent ischemic heart disease within 6 months
- Heart failure or left ventricular ejection fraction ≤50%
- Significant ECG abnormalities or symptomatic arrhythmia
- Use of medications that increase risk of torsades de pointes which cannot be stopped
- Use of cardiac pacemaker
- Active infection requiring systemic treatment
- Known HIV or chronic active hepatitis B or C infection
- Other major illnesses increasing risk for study participation
- Symptomatic or progressing central nervous system disease requiring steroids
- Carcinomatous meningitis
- Prior bone marrow or stem cell transplantation
- Previous treatment with trabectedin, lurbinectedin, or ecubectedin
- Use of strong or moderate CYP3A4 inhibitors or inducers within 2 weeks before first PM54 infusion
- Known allergy to components of PM54
- Inability to comply with treatment or protocol procedures
- Pregnancy or breastfeeding
- Fertile patients not using highly effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229-3307
Actively Recruiting
2
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
3
HM Universitario Sanchinarro
Madrid, M, Spain, 28050
Actively Recruiting
Research Team
C
Cristian M Fernández, M.D.
CONTACT
G
Gaston Federico Boggio, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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