Phase 1/2 Randomized, Controlled, Open-label Trial of Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ Unresectable Hepatocellular Carcinoma (HCC)
RayzeBio, Inc.
Summary
Phase 1/2 randomized, controlled, open-label trial of theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable hepatocellular carcinoma (HCC)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age of at least 18 years at the time of signing the informed consent form (ICF) * Histologically/cytologically confirmed diagnosis of HCC. * Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC Stage B not amenable to locoregional therapy * Child-Pugh A * Eastern Cooperative Oncology Group (ECOG) performance status (PS 0-1) * Disease progression after 1 prior systemic therapy for unresectable HCC * Measurable disease per RECIST v1.1 * Sufficient renal function * Adequate hematologic function * Adequate hepatic function * The subject must have recovered from toxicities re…
Interventions
- Diagnostic TestRYZ811
Ga-68
- DrugRYZ801
Ac-225
Locations (13)
- Research FacilityBirmingham, Alabama
- Research FacilityPhoenix, Arizona
- Research FacilityTucson, Arizona
- Research FacilityOrange, California
- Research FacilityJacksonville, Florida
- Research FacilityLexington, Kentucky