A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors
Synnovation Therapeutics, Inc.
Summary
This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Advanced or metastatic solid tumor malignancy * Evaluable or Measurable disease (RECIST 1.1 Criteria). * ECOG Performance Status 0 or 1. * Life expectancy \> 3 months Exclusion Criteria: * History of other malignancy within the past 2 years * Prior diagnosis of Myelodysplastic syndrome or Acute Myeloid Leukemia * Significant cardiovascular disease within 6 months * Significant gastrointestinal disease * HIV infection with a CD4+ T-cell count \< 200 cells/μL and/or a detectable viral load * Liver dysfunction
Interventions
- DrugSNV1521
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
- DrugDB-1310
DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.
- DrugAbiraterone
Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions.
- DrugDarolutamide
Darolutamide is taken orally. Dose and frequency are per approved prescribing instructions.
Locations (21)
- Smilow Cancer Hospital at Yale New HavenNew Haven, Connecticut
- Thomas Jefferson UniversityPhiladelphia, Pennsylvania
- Sarah Cannon Research InstituteNashville, Tennessee
- The University of Texas M.D. Anderson Cancer CenterHouston, Texas
- START Center for Cancer CareWest Valley City, Utah
- Scientia Clinical ResearchRandwick, New South Wales