A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
ARC-12
A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies
3 other identifiers
interventional
94
3 countries
22
Brief Summary
This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2021
Longer than P75 for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 26, 2021
CompletedStudy Start
First participant enrolled
March 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2025
CompletedAugust 28, 2025
September 1, 2024
4.4 years
February 22, 2021
August 27, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of participants with Adverse Events
From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
Percentage of participants who experience a Dose Limiting Toxicity
From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)
Secondary Outcomes (7)
Serum concentration of AB308
Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Serum concentration of zimberelimab
Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with anti-drug antibodies to AB308
Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with anti-drug antibodies to zimberelimab
Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with Objective Response
From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 3-5 years)
- +2 more secondary outcomes
Study Arms (8)
Dose Escalation Q3W Cohorts
EXPERIMENTALEscalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies.
Dose Escalation Q4W Cohorts
EXPERIMENTALEscalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies.
Dose Escalation Q6W Cohort
EXPERIMENTALSelected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.
Dose Expansion Cohort 1
EXPERIMENTALAB308 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.
Dose Expansion Cohort 2
EXPERIMENTALAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma.
Dose Expansion Cohort 3
EXPERIMENTALAB308 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.
Dose Expansion Cohort 4
EXPERIMENTALAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer.
Dose Expansion Cohort 5
EXPERIMENTALAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies.
Interventions
Administered intravenously (IV) as specified in the treatment arm
Administered IV as specified in the treatment arm
Eligibility Criteria
You may qualify if:
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- 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
You may not qualify if:
- History of trauma or major surgery within 28 days prior to the first dose of study treatment.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arcus Biosciences, Inc.lead
- Gilead Sciencescollaborator
Study Sites (22)
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095, United States
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, 32224, United States
Goshen Health System
Goshen, Indiana, 46526, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Norton Cancer Insititute-Downtown
Louisville, Kentucky, 40202, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Columbia University Medical Center
New York, New York, 10032-3729, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15240, United States
Tennessee Onocology - Nashville
Nashville, Tennessee, 37205, United States
START South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229, United States
START South Texas Accelerated Research Therapeutics - Mountain Region
West Valley City, Utah, 84119, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22033-1712, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53792, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Arcus Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2021
First Posted
February 26, 2021
Study Start
March 19, 2021
Primary Completion
August 25, 2025
Study Completion
August 25, 2025
Last Updated
August 28, 2025
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
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.