SMP-3124LP in Adults With Advanced Solid Tumors
Trial Parameters
Brief Summary
An Open-label, Phase I Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Preliminary Antitumor Activity of SMP 3124LP in Adults with Advanced Solid Tumors
Eligibility Criteria
Inclusion Criteria: \- Histologically or cytologically-confirmed cancer that is advanced, recurrent, or metastatic with the following origins, and whose disease progressed on standard therapy and for whom there are no alternative therapies that may confer overall survival benefit. For patients in the Dose Escalation part: 1. Platinum-resistant ovarian cancer * Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features (serous and clear cell) * Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy 2. Triple negative breast cancer - ER- and PR-negative with HER2 negative * HER2 negative is defined as one of the following: 0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines * ER- and PR-negative is defined as \< 10% of cells expressing hormonal receptors by IHC, as per standard guidelines 3. Squamous cell