Clinical Trial of PM54 in Advanced Solid Tumors Patients.
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharmaMar
About this trial
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.
Eligibility criteria
Qualifiers
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.
Genitourinary tract tumors: urothelial carcinoma, clear cell renal carcinoma and prostate adenocarcinoma.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PM54
Treatment groups
125 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov