A Phase 1 interventional study of AB598 and Zimberelimab in Advanced Cancer, Advanced Malignancies and Bladder Cancer, sponsored by Arcus Biosciences, Inc.. Active, not recruiting at 14 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Arcus Biosciences, Inc. · Phase 1, Interventional, and Treatment
The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.
Key Inclusion Criteria:
Monotherapy-specific criteria for dose escalation and PD cohorts:
Dose Expansion cohort criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will receive AB598 intravenous (IV) infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab and FOLFOX (oxaliplatin, leucovorin, fluorouracil)
Drug: AB598 · Drug: Zimberelimab · Drug: Fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Also known as: AB122
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 2 years
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Up to 2 years
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
Time frame: Predose, Up to 4 hours post dose
Maximum Concentration (Cmax) in Whole Blood and Plasma
Time frame: Predose, Up to 4 hours post dose
Time to Maximum Concentration (Tmax) in Whole Blood and Plasma
Time frame: Predose, Up to 4 hours post dose
Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598
Time frame: Up to 2 years
Objective Response Rate (ORR)
Time frame: Up to 2 years
Dose Expansion Cohort: Duration of Response (DOR)
Time frame: Up to 2 years
Plan to share: Yes — Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
Supporting information: Study protocol, Sap, Csr
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Arcus Biosciences, Inc.