PM534 Administered Intravenously to Patients With Advanced Solid Tumors
ConditionPatients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharmaMar
About this trial
The goals of this trial are to identify the dose limiting toxicities, to determine the maximum tolerated dose and the recommended dose of PM534 in patients with advanced solid tumors. All Patients will receive PM534 via intravenous.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily signed and dated written informed consent, obtained prior to any specific study procedure.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
Patients with measurable or non-measurable disease according to the RECIST v.1.1.
Recovery to grade ≤1 from drug-related adverse events (AEs) of previous disease treatments, excluding grade 2 alopecia.
Disqualifiers
History of long QT syndrome.
Corrected QT interval (QTcF, Fridericia correction) ≥450 msec on screening electrocardiogram (ECG).
History of or current ischemic heart disease, including myocardial infarction, stable/unstable angina, coronary arteriography or cardiac stress testing with findings consistent with coronary occlusion or infarction or symptomatic arrhythmia.
History of heart failure or left ventricular dysfunction (left ventricular ejection fraction [LVEF] ≤50%) by multiple-gated acquisition scan (MUGA) or echocardiography (ECHO).
Trial design
Design model
Sequential
Treatments tested in this trial
PM534
DrugPM534 drug product is provided as a powder for concentrate for solution for infusion, is a sterile, preservative-free, lyophilized white cake in a single-dose vial for reconstitution prior to intravenous infusion.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: PM534Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Determination of the Maximum Tolerated Dose and the Recommended Dose
A fully evaluable patient is a patient evaluable for the primary objective (i.e., determination of the MTD and the RD).
Time frame
From the date of first infusion of PM534 to the date of study termination, up to 46 monthsSecondary outcomes
1
Safety AEs of PM534
AEs will be graded according to the NCI-CTCAE v.5.
Time frame
From the date of first infusion of PM534 to the date of study termination, up to 46 months2
Safety Hb of PM534
Parameters Labs will be graded according to the NCI-CTCAE v.5.
Time frame
From the date of first infusion of PM534 to the date of study termination, up to 46 months3
Safety neutrophils of PM534
Parameters Labs will be graded according to the NCI-CTCAE v.5.
Time frame
From the date of first infusion of PM534 to the date of study termination, up to 46 months4
Safety platelets of PM534
Parameters Labs will be graded according to the NCI-CTCAE v.5.
Time frame
From the date of first infusion of PM534 to the date of study termination, up to 46 months Source ClinicalTrials.gov