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Zimberelimab

Phase 2

Hepatobiliary Cancer | Small molecule | Oncology |Arcus Biosciences, Inc.|Last Updated: May 21, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05724563Domvanalimab and Zimberelimab in Advanced Liver CancersPHASE2 ACTIVE NOT_RECRUITING 58Jun 1, 2023Jun 1, 2027May 21, 20251 United States
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Study Endpoints
Primary Endpoints
Objective Response rate of combination zimberelimab and domvanalimab.
Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months

To determine the best objective response rate assessed by RECIST guidelines (version 1.1) of combination zimberelimab and domvanalimab in patients with advanced hepatobiliary cancers previously exposed to anti-PD-1/L1 antibody treatments.

Secondary Endpoints
Disease Control Rate of combination zimberelimab and domvanalimab
Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Overall survival of combination zimberelimab and domvanalimab
Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
6-month progression-free survival of combination zimberelimab and domvanalimab
Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Zimberelimab and DomvanalimabEXPERIMENTALIndividual will be given Zimberelimab (AB122) 360 mg IV in a 1 hour infusion + 30 minute rest + Domvanalimab (AB154) 1200 mg IV in a 1 hour infusion every three weeks. Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason
Interventions
NameTypeDescription
ZimberelimabDRUGZimberelimab 360 mg IV every 3 weeks until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason.
DomvanalimabDRUGDomvanalimab 1200 mg IV every 3 weeks until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patient must have a histologically confirmed diagnosis consistent with HCC or bile duct cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancers); known fibrolamellar HCC, or combined HCC-cholangiocarcinoma will be excluded....

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05724563primaryCompletionDate: changed
LOWMay 24, 2026NCT05724563studyFirstPostDate: changed