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RYZ801

Phase 1

HCC | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: May 24, 2025

RYZ801 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2001

RYZ801 target and mechanism

Molecular targetBCMA
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

RYZ801 clinical trials

RYZ801 · 1 trial · 1 indication

Phase 1 1
NCT06726161Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ Unresectable HCCHCC
RECRUITING70 Analytics
PHASE1RECRUITING
Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ Unresectable HCC
HCCUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
RYZ811DIAGNOSTIC_TESTGa-68
RYZ801DRUGAc-225
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Frequently asked questions about RYZ801

What is RYZ801?

RYZ801 is an investigational small molecule therapeutic being developed by Bristol-Myers Squibb Company (ticker: BMY) for hepatocellular carcinoma (HCC), a form of liver cancer. It is in Phase 1 clinical development and is designed for use as part of a theranostic pair alongside a diagnostic agent, RYZ811.

What is RYZ801 used for in HCC?

RYZ801 is being studied for the treatment of GPC3-positive unresectable hepatocellular carcinoma (HCC). It is intended for use with the diagnostic agent RYZ811, which identifies patients whose tumors express GPC3 so that the therapeutic can then be given to that biomarker-selected population.

What does RYZ801 target?

RYZ801 targets BCMA, a protein. It is a small molecule therapeutic, and the clinical program pairs it with the diagnostic agent RYZ811 to identify and treat subjects with GPC3-positive unresectable hepatocellular carcinoma.

Who is developing RYZ801?

RYZ801 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is running the Phase 1 study of the therapeutic as part of a theranostic pair with the diagnostic agent RYZ811 in GPC3-positive unresectable hepatocellular carcinoma.

What phase is RYZ801 in?

RYZ801 is in Phase 1 clinical development. It is an investigational agent and has not been approved for any indication. The Phase 1 program is currently recruiting participants and is designed to evaluate the therapeutic in a biomarker-selected population of patients with GPC3-positive unresectable hepatocellular carcinoma.

What clinical trials is RYZ801 in?

RYZ801 is being studied in one active clinical trial, NCT06726161, titled "Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ Unresectable HCC." The trial is a Phase 1, recruiting, uncontrolled study with a planned enrollment of 70 participants.