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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
PM54
DrugPM54 powder for concentrate for solution for infusion (3 mg/vial) is a sterile, preservative-free, lyophilized white to yellowish cake in a single-dose vial for reconstitution prior to intravenous infusion. Each vial contains 3 mg PM54. Route of administration: Intravenous infusion
Treatment groups
125 Participants
are divided into 1 treatment groupGroup A: PM54Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1a (dose escalation) and Phase1b (safety run-in): Dose-limiting toxicities (DLTs)
Time frame
Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)2
Phase 1a (dose escalation) and Phase1b (safety run-in): Treatment-emergent Adverse Events (TEAEs)
Time frame
Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)3
Phase 1a (dose escalation) and Phase1b (safety run-in): Drug-related Adverse Events (AEs)
Time frame
Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)4
Phase 1a (dose escalation) and Phase1b (safety run-in): Drug-related deaths
Time frame
Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)Secondary outcomes
1
Phase 1b (expansion): Adverse events (AEs)
AEs will be graded according to the NCI-CTCAE v.5.
Time frame
Screening to end of study (up to approximately 48 months)2
Phase 1b (expansion): Treatment discontinuation
Time frame
Day 1 up to end of study (up to approximately 48 months)3
Phase 1b (expansion): Dose reductions
Time frame
Day 1 up to end of study (up to approximately 48 months)4
Phase 1b (expansion): Treatment delays due to adverse events (AEs)
Time frame
Day 1 up to end of study (up to approximately 48 months) Source ClinicalTrials.gov