Phase 1 First-in-Human, Dose Escalation and Dose Expansion Study of RYZ401, a Novel Radiopharmaceutical Therapy Labeled With Actinium-225, in Subjects With Neuroendocrine Tumors and Other Solid Tumors Expressing Somatostatin Receptors.
Summary
The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate preliminary efficacy of RYZ401 in subjects with NETs and other selected solid tumors expressing SSTRs.
Arms & interventions
- DrugRYZ401
Ac-225
Outcome measures
Primary
Dose Escalation
Incidence of DLTs during RYZ 401 Treatment
Time frame: Incidence of DLTs during the first 4 weeks of RYZ401 treatment
Dose Expansion
Incidence, severity, and duration of AEs
Time frame: Cycle1 Day 1 to LPFV + 6 weeks
Eligibility criteria
Study locations (7)
Research Facility
Iowa City, Iowa, 52242
Research Facility
Lexington, Kentucky, 40536
Research Facility
St Louis, Missouri, 63104
Research Facility
St Louis, Missouri, 63110
Research Facility
Columbus, Ohio, 43210
Research Facility
Nashville, Tennessee, 37232
Research Facility
Salt Lake City, Utah, 84112