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AB598

Phase 1

Advanced Cancer | Small molecule | Oncology |Arcus Biosciences, Inc.|Trials Updated: Sep 29, 2026

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2023

Target and mechanism

Molecular targetCD39
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

AB598 · 1 trial · 12 indications

Phase 1 1
NCT05891171Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced CancersAdvanced Cancer
ACTIVE NOT_RECRUITING40 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
Advanced CancerUnlock trial analytics

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 to 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 (matched to "Advanced Cancer")

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Recent Changes (Last 90 Days)

LOWSep 29, 2026NCT05891171lastUpdatePostDate: changed
LOWSep 29, 2026NCT05891171lastUpdatePostDate: changed
LOWAug 31, 2026NCT05891171lastUpdatePostDate: changed
LOWAug 31, 2026NCT05891171lastUpdatePostDate: changed
LOWJul 30, 2026NCT05891171lastUpdatePostDate: changed
LOWJul 30, 2026NCT05891171lastUpdatePostDate: changed

Frequently asked questions about AB598

What is AB598 used for in advanced cancer?

AB598 is an investigational small molecule being studied for the treatment of advanced cancers, including bladder, cervical, esophageal, gastric, gastroesophageal-junction, head and neck squamous cell carcinoma, non-small cell lung, ovarian, renal cell, and triple negative breast cancers. It is currently in Phase 1 clinical development and is not yet approved.

What does AB598 target?

AB598 targets CD39, a cell surface enzyme involved in the adenosine pathway that can suppress anti-tumor immune responses. By inhibiting CD39, AB598 is designed to modulate the tumor microenvironment and potentially enhance the body's immune response against cancer cells.

Who makes AB598?

AB598 is being developed by Arcus Biosciences, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol RCUS. The company is conducting clinical trials to evaluate the safety and efficacy of AB598 in patients with advanced malignancies.

What phase is AB598 in?

AB598 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for safety and preliminary efficacy in patients with advanced cancers.

What clinical trials is AB598 in?

AB598 is being studied in a Phase 1 clinical trial with the identifier NCT05891171, titled 'Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers.' The trial is active but not recruiting, with an estimated enrollment of 40 participants across the United States, Australia, and Taiwan.

Is AB598 the same as any other drug?

AB598 is a distinct investigational small molecule targeting CD39. No alternative names for AB598 have been disclosed in the available clinical trial information. It is being evaluated as a monotherapy and in combination with other agents in the ongoing Phase 1 study.