Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
RayzeBio, Inc.
Study ID
NCT06726161
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RYZ811 — DIAGNOSTIC_TEST
    Ga-68
  • RYZ801 — DRUG
    Ac-225

Study Details

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)

Key Dates

Start date
Sep 5, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
590 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation, Dose Expansion (Dose Optimization/Randomized Phase 2)
  • Active Comparator: Standard of Care (SoC) (Randomized Phase 2)

Primary Outcome Measure

Therapeutic - RYZ801 [ Time Frame: Rate of DLTs during the first 42 days of study treatment ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Research FacilityBirminghamAlabama35233-
Research FacilityPhoenixArizona85054-
Research FacilityTucsonArizona85719-
Research FacilityOrangeCalifornia92868-
Research FacilityJacksonvilleFlorida32224-
Research FacilityLexingtonKentucky40536-
Research FacilityBaltimoreMaryland21287-
Research FacilityRochesterMinnesota55905-
Research FacilityOmahaNebraska68130-
Research FacilityNew YorkNew York10065-
Research FacilityHoustonTexas77030-
Research FacilityCharlottesvilleVirginia22908-
Research FacilitySeattleWashington98109-

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Research Facility· Birmingham, ALResearch Facility· Phoenix, AZResearch Facility· Tucson, AZResearch Facility· Orange, CAResearch Facility· Jacksonville, FLResearch Facility· Lexington, KY

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