Phase I/Ib, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM54 Administered Intravenously to Patients With Selected Advanced Solid Tumors.
PharmaMar
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Voluntarily signed and dated written informed consent, obtained prior to any specific study procedure. 2. Age ≥18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1. 4. Phase Ia (dose escalation) stage: patients must have: 1. Pathologically confirmed diagnosis of advanced solid tumors for whom no standard therapy exists: * Genitourinary tract tumors: urothelial carcinoma, clear cell renal carcinoma and prostate adenocarcinoma. * Cutaneous melanoma. * Gastrointestinal: esophageal adenocarcinoma, gastric adenocarcinoma, p…
Interventions
- DrugPM54
PM54 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
Locations (3)
- South Texas Accelerated Research TherapeuticsSan Antonio, Texas
- Institut Jules BordetAnderlecht
- HM Universitario SanchinarroMadrid, M