Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
NCT ID: NCT05891171
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2023-10-13
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Cohort 1
Participants will receive AB598 intravenous (IV) infusion once every 3 weeks
AB598
Administered as specified in the treatment arm
Dose Escalation Cohort 2
Participants will receive AB598 IV infusion once every 3 weeks
AB598
Administered as specified in the treatment arm
Dose Escalation Cohort 3
Participants will receive AB598 IV infusion once every 3 weeks
AB598
Administered as specified in the treatment arm
Dose Escalation Cohort 4
Participants will receive AB598 IV infusion once every 3 weeks
AB598
Administered as specified in the treatment arm
Pharmacodynamic Cohort 1
Participants will receive AB598 IV infusion once every 3 weeks
AB598
Administered as specified in the treatment arm
Pharmacodynamic Cohort 2
Participants will receive AB598 IV infusion once every 3 weeks
AB598
Administered as specified in the treatment arm
Pharmacodynamic Cohort 3
Participants will receive AB598 IV infusion once every 3 weeks
AB598
Administered as specified in the treatment arm
Dose Expansion Gastric/GEJ Cancer (phase 1b)
Participants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab and FOLFOX (oxaliplatin, leucovorin, fluorouracil)
AB598
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Fluorouracil
Administered as specified in the treatment arm
Leucovorin
Administered as specified in the treatment arm
Oxaliplatin
Administered as specified in the treatment arm
Interventions
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AB598
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Fluorouracil
Administered as specified in the treatment arm
Leucovorin
Administered as specified in the treatment arm
Oxaliplatin
Administered as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Arcus Biosciences
Locations
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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
Next Oncology Virginia
Fairfax, Virginia, United States
Adelaide Cancer Research
Adelaide, , Australia
Queen Elizabeth Hospital
Adelaide, , Australia
National Cheng Kung University Hospital
Tainan, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Related Links
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ARC-25 - Public website
Other Identifiers
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ARC-25
Identifier Type: -
Identifier Source: org_study_id
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