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

ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRayzeBio, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Subjects with fibrolamellar carcinoma, sarcomatoid HCC or combined hepatocellular cholangiocarcinoma

Prior liver transplantation

Known hypersensitivity to 68Ga, 225Ac or any of the excipients of RYZ811 or RYZ801

Portal vein tumor thrombosis classified as Vp4

Trial design

Design model

Sequential

Treatments tested in this trial

  • RYZ811

    Diagnostic test

    Ga-68

  • RYZ801

    Drug

    Ac-225

Treatment groups

590 Participants
are divided into 2 treatment groups
Group A: Dose Escalation, Dose Expansion (Dose Optimization/Randomized Phase 2)Experimental treatment 2 interventions
Group B: Standard of Care (SoC) (Randomized Phase 2)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Therapeutic - RYZ801

To determine the RTA of RYZ801 in subjects with GPC3+ unresectable HCC (Dose Escalation only)

Time frame
Rate of DLTs during the first 42 days of study treatment
2

Therapeutic - RYZ801

To determine if treatment with RYZ801, compared to SoC therapy, improves ORR in subjects with GPC3+ unresectable HCC (Dose Expansion Stage 2 only) using ORR (rate of CR or PR), as determined by BICR according to RECIST v1.1

Time frame
From enrollment for up to three months or study discontinuation, whichever occurs first.
3

Therapeutic - RYZ801

To evaluate ORR of RYZ801 different dosing regimens (Dose Expansion Stage 1 only) and determine dosage optimized RP2D using ORR (rate of confirmed CR or PR) by RECIST v1.1 per investigator assessment

Time frame
From enrollment to 3months after randomization or study discontinuation, whichever occurs first.
4

Diagnostic - RYZ811

To assess the safety and tolerability of RYZ811 in subjects with unresectable HCC. Safety and tolerability of RYZ811 as measured by incidence and severity of AEs, including SAEs, laboratory changes, and other safety findings.

Time frame
Baseline, pre-injection and post-injection up to 6 days post injection.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RayzeBio, Inc.

Lead sponsor

Source ClinicalTrials.gov
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