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AB598

Phase 1

Advanced Cancer | Small molecule | Oncology |Arcus Biosciences, Inc.|Last Updated: Aug 31, 2026

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")

Recent Changes (Last 90 Days)

LOWAug 31, 2026NCT05891171lastUpdatePostDate: changed
LOWAug 31, 2026NCT05891171lastUpdatePostDate: changed
LOWJul 30, 2026NCT05891171lastUpdatePostDate: changed
LOWJul 30, 2026NCT05891171lastUpdatePostDate: changed
LOWJul 2, 2026NCT05891171lastUpdatePostDate: changed
LOWJul 2, 2026NCT05891171lastUpdatePostDate: changed
LOWJul 2, 2026NCT05891171lastUpdatePostDate: changed
LOWJul 2, 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 cancer. It is currently in Phase 1 clinical development.

Who is developing AB598?

AB598 is being developed by Arcus Biosciences, Inc. (NYSE: RCUS). The company is conducting a Phase 1 clinical trial of AB598 as a monotherapy and in combination with other agents for the treatment of advanced cancers.

What phase is AB598 in?

AB598 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 study is evaluating the safety and tolerability of AB598 in participants with advanced malignancies.

What clinical trials is AB598 in?

AB598 is being studied in a Phase 1 clinical trial with the identifier NCT05891171. This trial is titled "Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers" and is currently active but not recruiting participants.

Is AB598 being studied in combination with other therapies?

Yes, the Phase 1 clinical trial of AB598 is designed to evaluate AB598 both as a monotherapy and in combination therapy. The study is enrolling participants with various advanced solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, and triple negative breast cancer.