A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
NCT ID: NCT04772989
Last Updated: 2025-08-28
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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COMPLETED
PHASE1
94 participants
INTERVENTIONAL
2021-03-19
2025-08-25
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 Q3W Cohorts
Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies.
AB308
Administered intravenously (IV) as specified in the treatment arm
Zimberelimab
Administered IV as specified in the treatment arm
Dose Escalation Q4W Cohorts
Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies.
AB308
Administered intravenously (IV) as specified in the treatment arm
Zimberelimab
Administered IV as specified in the treatment arm
Dose Escalation Q6W Cohort
Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.
AB308
Administered intravenously (IV) as specified in the treatment arm
Zimberelimab
Administered IV as specified in the treatment arm
Dose Expansion Cohort 1
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with in participants with locally advanced or metastatic NSCLC.
AB308
Administered intravenously (IV) as specified in the treatment arm
Zimberelimab
Administered IV as specified in the treatment arm
Dose Expansion Cohort 2
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma.
AB308
Administered intravenously (IV) as specified in the treatment arm
Zimberelimab
Administered IV as specified in the treatment arm
Dose Expansion Cohort 3
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer.
AB308
Administered intravenously (IV) as specified in the treatment arm
Zimberelimab
Administered IV as specified in the treatment arm
Dose Expansion Cohort 4
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer.
AB308
Administered intravenously (IV) as specified in the treatment arm
Zimberelimab
Administered IV as specified in the treatment arm
Dose Expansion Cohort 5
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies.
AB308
Administered intravenously (IV) as specified in the treatment arm
Zimberelimab
Administered IV as specified in the treatment arm
Interventions
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AB308
Administered intravenously (IV) as specified in the treatment arm
Zimberelimab
Administered IV as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female participants ≥ 18 years of age (or age ≥ regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Adequate organ and marrow function
Exclusion Criteria
* Prior treatment with an anti-TIGIT antibody.
* Any active or prior autoimmune disease that required treatment within 3 years of the first dose of study treatment.
* Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic agents, or use of other investigational drugs within 28 days before first dose of study treatment.
* Discontinued prior immunotherapy for immune related adverse events with a high severity.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
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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UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, United States
Goshen Health System
Goshen, Indiana, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Norton Cancer Insititute-Downtown
Louisville, Kentucky, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Tennessee Onocology - Nashville
Nashville, Tennessee, United States
START South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
START South Texas Accelerated Research Therapeutics - Mountain Region
West Valley City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
Lubin, , Poland
Med-Polonia Sp. z o.o.
Poznan, , Poland
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Clínica Universidad de Navarra - Madrid
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
START MADRID Hospital Unviersitario Fundacion Jimenez Diaz
Madrid, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Countries
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Related Links
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ARC-12 - Public website
Other Identifiers
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2021-005589-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-511116-25-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARC-12
Identifier Type: -
Identifier Source: org_study_id
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