An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With Advanced Solid Tumors
Sumitomo Pharma America, Inc.
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
Description
Phase 1/2, global, multicenter, open-label, first-in-human, clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of SMP-3124
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 month…
Interventions
- DrugSMP3124LP
Liposomal encapsulation formulation of SMP-3124
Locations (10)
- Cedars Sinai Medical CenterLos Angeles, California
- Sarah Cannon Research Institute at HealthOneDenver, Colorado
- Northwestern Medicine Cancer CenterChicago, Illinois
- Ohio State UniversityColumbus, Ohio
- SCRI Oncology PartnersNashville, Tennessee
- Vanderbilt-Ingram Cancer CenterNashville, Tennessee