Active Not RecruitingPhase 1NCT05891171

Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.

Checked against the public recordLast updated Jul 30, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1
U.S. locations14
SponsorArcus Biosciences, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Arcus Biosciences, Inc.
Interventions being studied
Drug: AB598; Drug: Zimberelimab; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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 least 4 weeks before investigational product (IP) administration. Other palliative radiotherapy must be completed 2 weeks before investigational product administration, if radiation therapy-related AEs have resolved to Grade ≤ 1. * Monotherapy-specific criteria for dose escalation and PD cohorts: * Dose Escalation: Participants may have any pathologically confirmed advanced or metastatic solid tumor for which standard therapy has proven ineffective, intolerable, or is considered inappropriate. * Pharmacodynamic Cohorts: Participants may have any pathologically confirmed advanced or metastatic solid tumors for which standard therapy has proven ineffective, intolerable, or is considered inappropriate. Participants must be able to undergo collection of a fresh frozen biopsy during screening, as well as provide an on-treatment fresh frozen biopsy. * Dose Expansion cohort criteria: * Histologically confirmed, documented diagnosis of HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. * No prior systemic treatment for locally advanced unresectable or metastatic disease. * Cannot have progressed within 6 months of prior platinum-based chemotherapy for earlier stage disease. Key Exclusion Criteria: * Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study * Underlying medical conditions or AEs that, in the investigator or sponsor's opinion, will make the administration of the study drugs hazardous * Any active or documented history of autoimmune disease including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment * History of trauma or major surgery within 28 days prior to the first dose of study drug * Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment with certain protocol specified exceptions Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SitePhoenix, Arizona
  • Research SiteJacksonville, Florida
  • Research SiteLake City, Florida
  • Research SiteHinsdale, Illinois
  • Research SiteDetroit, Michigan
  • Research SiteRochester, Minnesota
  • Research SiteNew Brunswick, New Jersey
  • Research SiteCanton, Ohio
  • Research SiteCleveland, Ohio
  • Research SiteIrving, Texas
  • Research SiteFairfax, Virginia
  • Research SiteAdelaide

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 30, 2026. Always confirm current availability with the study team.

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