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AB598

Phase 1

Advanced Cancer | Small molecule | Oncology |Arcus Biosciences, Inc.|Last Updated: Jun 5, 2026

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05891171Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced CancersPHASE1 ACTIVE NOT_RECRUITING 40 — — Oct 13, 2023Sep 1, 2027Jun 5, 202614 United States, Australia +1
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 2 years
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)
Up to 2 years
Secondary Endpoints
Area Under the Concentration-Time Curve from Administration ("0") to the Time That the Drug is No Longer Present in the Body ("infinity") (AUC 0-inf) in Whole Blood and Plasma
Predose, Up to 4 hours post dose
Maximum Concentration (Cmax) in Whole Blood and Plasma
Predose, Up to 4 hours post dose
Time to Maximum Concentration (Tmax) in Whole Blood and Plasma
Predose, Up to 4 hours post dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation Cohort 1EXPERIMENTALParticipants will receive AB598 intravenous (IV) infusion once every 3 weeks
Dose Escalation Cohort 2EXPERIMENTALParticipants will receive AB598 IV infusion once every 3 weeks
Dose Escalation Cohort 3EXPERIMENTALParticipants will receive AB598 IV infusion once every 3 weeks
Dose Escalation Cohort 4EXPERIMENTALParticipants will receive AB598 IV infusion once every 3 weeks
Pharmacodynamic Cohort 1EXPERIMENTALParticipants will receive AB598 IV infusion once every 3 weeks
Pharmacodynamic Cohort 2EXPERIMENTALParticipants will receive AB598 IV infusion once every 3 weeks
Pharmacodynamic Cohort 3EXPERIMENTALParticipants will receive AB598 IV infusion once every 3 weeks
Dose Expansion Gastric/GEJ Cancer (phase 1b)EXPERIMENTALParticipants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab and FOLFOX (oxaliplatin, leucovorin, fluorouracil)
Interventions
NameTypeDescription
AB598DRUGAdministered as specified in the treatment arm
ZimberelimabDRUGAdministered as specified in the treatment arm
FluorouracilDRUGAdministered as specified in the treatment arm
LeucovorinDRUGAdministered as specified in the treatment arm
OxaliplatinDRUGAdministered as specified in the treatment arm
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Key Inclusion Criteria: * Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Prior systemic radiation or whole brain radiation therapy must have been completed at ...

Countries:United StatesAustraliaTaiwan
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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Recent Changes (Last 90 Days)
MEDIUMJun 5, 2026NCT05891171primaryCompletionDate: changed
MEDIUMJun 5, 2026NCT05891171primaryCompletionDate: changed
MEDIUMJun 5, 2026NCT05891171primaryCompletionDate: changed
MEDIUMJun 5, 2026NCT05891171primaryCompletionDate: changed
LOWMay 26, 2026NCT05891171primaryCompletionDate: changed
LOWMay 24, 2026NCT05891171studyFirstPostDate: changed