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

Detailed criteria

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…

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)

Summary

Eligibility

Interventions

Locations (13)