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Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers | Clinical Trials | Clareo Health

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

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

NCT05891171•Arcus Biosciences, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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

Locations (15)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Lake City Cancer Care, LLC.

Lake City, Florida, United States

Affinity Health Hope and Healing Cancer Services, LLC

Hinsdale, Illinois, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Gabrail Cancer Center (GCC) Canton Facility

Canton, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Next Oncology Dallas

Irving, Texas, United States

Key Dates

Start Date

October 13, 2023

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

February 27, 2026

Enrollment

ACTUAL participants

Conditions

Advanced CancerAdvanced MalignanciesBladder CancerCervical CancerEsophageal CancerGastric CancerGastroesophageal-junction Cancer (GEJ)Head and Neck Squamous Cell Carcinoma (HNSCC)Non-Small Cell Lung Cancer (NSCLC)Ovarian CancerRenal Cell Carcinoma (RCC)Triple Negative Breast Cancer (TNBC)

Interventions

AB598

DRUG

Zimberelimab

DRUG

Fluorouracil

DRUG

Leucovorin

DRUG

Oxaliplatin

DRUG

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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Advanced Bladder CarcinomaAdvanced Genitourinary System Carcinoma+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery