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
Qualifiers
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
Treatments tested in this trial
- PM534
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov