A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies
NCT ID: NCT04104672
Last Updated: 2026-01-05
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
196 participants
INTERVENTIONAL
2019-11-06
2027-05-31
Brief Summary
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Detailed Description
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In the dose expansion portion of the study in front-line (1L) pancreatic patients, participants will receive AB680 at the RP2D determined from the dose escalation study in combination with zimberelimab at the RP2D and nab-paclitaxel and gemcitabine at standard doses or AB680 at the RP2D in combination with nab-paclitaxel and gemcitabine at standard doses. In the dose-expansion portion of the study in second-line (2L) pancreatic patients, participants will receive AB680 at the RP2D determined from the dose-escalation study in combination with zimberelimab at the RP2D and nab-paclitaxel and gemcitabine at standard doses.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The dose expansion dose level will be determined in this part with escalating doses of AB680 in combination with zimberelimab at the recommended phase 2 dose (RP2D) and the standard nab-paclitaxel and gemcitabine chemotherapy regimen in participants with advanced pancreatic cancer.
AB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor.
Zimberelimab
Zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1.
Nab-paclitaxel
Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Gemcitabine
Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Dose Expansion (AB680+zimberelimab+ NP/Gem): Cohort A (front-line/1L)
Participants with advanced pancreatic cancer, naïve to any prior treatment will receive AB680 (at the RP2D identified during dose escalation) combined with zimberelimab and the standard nab-paclitaxel (NP) and gemcitabine (Gem) (NP/Gem) chemotherapy regimen
AB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor.
Zimberelimab
Zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1.
Nab-paclitaxel
Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Gemcitabine
Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Dose Expansion (AB680+zimberelimab+NP/Gem):Cohort A1 (front-line/1L)
Participants with advanced pancreatic cancer, naïve to any prior treatment will receive AB680 (at the RP2D identified during dose escalation) combined with zimberelimab and the standard nab-paclitaxel (NP) and gemcitabine (Gem) (NP/Gem) chemotherapy regimen
AB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor.
Zimberelimab
Zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1.
Nab-paclitaxel
Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Gemcitabine
Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Dose Expansion (AB680 + NP/Gem): Cohort A2 (front-line/1L)
Participants with advanced pancreatic cancer who are naïve to any prior treatment will receive AB680 (at the RP2D identified during dose escalation) and the standard NP/Gem chemotherapy regimen.
AB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor.
Nab-paclitaxel
Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Gemcitabine
Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Dose Expansion (AB680 + zimberelimab + NP/Gem): Cohort B (second-line/2L)
Participants with advance pancreatic cancer who have received 1 prior line of treatment will receive AB680 (at the RP2D identified during dose escalation) combined with zimberelimab and NP-Gem chemotherapy regimen.
AB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor.
Zimberelimab
Zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1.
Nab-paclitaxel
Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Gemcitabine
Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Dose Expansion (AB680 + zimberelimab + NP/Gem): Cohort C (front-line/1L)
Participants with advanced pancreatic cancer naïve to any prior treatment will receive AB680 combined with zimberelimab and NP-Gem chemotherapy regimen.
AB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor.
Zimberelimab
Zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1.
Nab-paclitaxel
Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Gemcitabine
Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Dose Expansion (AB680 + NP/Gem): Cohort D (front-line/1L)
Participants with advanced pancreatic cancer naïve to any prior treatment will receive AB680 combined with NP-Gem chemotherapy regimen.
AB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor.
Nab-paclitaxel
Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Gemcitabine
Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Interventions
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AB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor.
Zimberelimab
Zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1.
Nab-paclitaxel
Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Gemcitabine
Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naïve to any prior treatment, including chemotherapy, biological therapy, or targeted therapy for metastatic disease
* Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if neoadjuvant or adjuvant therapy was completed at least 6 months prior to study enrollment. Prior adjuvant therapy may include nab- paclitaxel or gemcitabine
* Participants initially diagnosed with locally advanced pancreatic cancer who have undergone chemotherapy then resection and had no evidence of disease are eligible if relapse of metastatic disease has occurred and if the last dose of chemotherapy was received more than 6 months before study entry
* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The measurable lesion must be outside of a radiation field if the participant received prior radiation
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Confirmation that an archival tissue sample is available; if not, a new biopsy of a tumor must be obtained
* Prior radiation therapy for metastatic disease must have been completed
* Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses \> 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before investigational product administration. Physiologic doses of corticosteroids (≤ 10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (≤ 3 days) may be permitted
* Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before investigational product administration
* Negative tests for hepatitis B surface antigen, hepatitis C virus antibody (or hepatitis C qualitative ribonucleic acid \[RNA; qualitative\]), and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
* Adequate organ and marrow function
Exclusion Criteria
* Any active autoimmune disease or a documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
* History of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
* Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
* Has not recovered (ie, ≤ Grade 1 or baseline) from a non-hematologic AEs due to a previously administered agent, except ≤ Grade 2 alopecia or ≤ Grade 2 neuropathy.
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, Inc.
Locations
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The Angeles Clinic
Los Angeles, California, United States
UCLA Hematology Oncology
Santa Monica, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mid-Florida Hematology & Oncology Centers, PA
Orange City, Florida, United States
BRCR Global
Plantation, Florida, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
NYU Cancer Institute
New York, New York, United States
Columbia University
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Canon Research Institute
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
START San Antonio
San Antonio, Texas, United States
Medical Oncology Associates
Spokane, Washington, United States
UW Health - UW Carbone Cancer Center - Medical Oncology Clinic
Madison, Wisconsin, United States
Countries
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Related Links
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ARC-8 - Public website
Other Identifiers
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ARC-8 (AB680CSP0002)
Identifier Type: -
Identifier Source: org_study_id
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