NCT05841563 Clinical Trial of PM54 in Advanced Solid Tumors Patients.
| NCT ID | NCT05841563 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | PharmaMar |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2023-04-28 |
| Primary Completion | 2026-12-30 |
Trial Parameters
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Brief 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 Criteria
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, pancreatic adenocarcinoma, and poorly differentiated (grade 3) gastroenteropancreatic Neuroendocrine Carcinoma (NEC )with Ki67 index \>55%. * Lung: non-small cell lung cancer (NSCLC) and Small Cell Lung Cancer (SCLC). * Gynecological tumors: epithelial ovarian carcinoma (including primary peritoneal disease and/or fallopian tube carcinomas), endometrial adenocarcinoma and carcinoma of cervix. * Breast: ductal or lobular.