A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03628677 |
Recruitment Status :
Recruiting
First Posted : August 14, 2018
Last Update Posted : October 1, 2018
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Condition or disease | Intervention/treatment | Phase |
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Non-small Cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck Renal Cell Carcinoma Breast Cancer Colorectal Cancer Melanoma Bladder Cancer Ovarian Cancer Endometrial Cancer Merkel Cell Carcinoma GastroEsophageal Cancer | Drug: AB154 Drug: AB122 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | 3+3 Dose Escalation Design |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Study to Evaluate the Safety and Tolerability of AB154 Monotherapy and Combination Therapy in Participants With Advanced Malignancies |
Actual Study Start Date : | August 21, 2018 |
Estimated Primary Completion Date : | October 31, 2019 |
Estimated Study Completion Date : | February 15, 2020 |

Arm | Intervention/treatment |
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Experimental: AB154 Monotherapy
Varying Doses of AB154 Monotherapy
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Drug: AB154
AB154 is a fully humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT |
Experimental: AB154 + AB122 Combination Therapy
Varying Doses of AB154 in Combination With the Selected Dose of AB122
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Drug: AB154
AB154 is a fully humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT Drug: AB122 AB122 is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1 |
- Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 [ Time Frame: From First Dose Date to 6 Months After Last Dose ]Number of Participants Treated with AB154 or AB154 in Combination with AB122 with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
- AB154 Peak Plasma Concentration (Cmax) [ Time Frame: Day 1 (sequential), Day 2, Day 3, Day 8, Day 15, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Peak Plasma Concentration (Cmax) of AB154
- AB122 Peak Plasma Concentration (Cmax) [ Time Frame: Day 1 (sequential), Day 2, Day 3, Day 8, Day 15, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Peak Plasma Concentration (Cmax) of AB122
- AB154 Time of Peak Concentration (Tmax) [ Time Frame: Day 1 (sequential), Day 2, Day 3, Day 8, Day 15, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Time of Peak Concentration (Tmax) of AB154
- AB122 Time of Peak Concentration (Tmax) [ Time Frame: Day 1 (sequential), Day 2, Day 3, Day 8, Day 15, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Time of Peak Concentration (Tmax) of AB122
- AB154 Area Under the Plasma Concentration Versus Time Curve (AUC) [ Time Frame: Day 1 (sequential), Day 2, Day 3, Day 8, Day 15, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Area Under the Plasma Concentration Versus Time Curve (AUC) of AB154
- AB122 Area Under the Plasma Concentration Versus Time Curve (AUC) [ Time Frame: Day 1 (sequential), Day 2, Day 3, Day 8, Day 15, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Area Under the Plasma Concentration Versus Time Curve (AUC) of AB122
- AB154 Receptor Occupancy [ Time Frame: Day 1, Day 3, Day 8, Day 15, Day 29, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Receptor Occupancy May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples
- AB154 Immunophenotyping [ Time Frame: Day 1, Day 3, Day 8, Day 15, Day 29, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Immunophenotyping May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples
- AB154 Gene Expression [ Time Frame: Day 1, Day 3, Day 8, Day 15, Day 29, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Gene Expression May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples
- AB154 Cytokines [ Time Frame: Day 1, Day 3, Day 8, Day 15, Day 29, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Cytokines May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples
- AB122 Receptor Occupancy [ Time Frame: Day 1, Day 3, Day 8, Day 15, Day 29, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Receptor Occupancy May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples
- AB122 Immunophenotyping [ Time Frame: Day 1, Day 3, Day 8, Day 15, Day 29, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Immunophenotyping May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples
- AB122 Cytokines [ Time Frame: Day 1, Day 3, Day 8, Day 15, Day 29, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Cytokines May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples
- AB122 Gene Expression [ Time Frame: Day 1, Day 3, Day 8, Day 15, Day 29, Day 31, Day 36, Day 43, Day 57, Day 85, and 30 Days After Last Dose, up to 52 weeks ]Gene Expression May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples
- Immunogenicity Indicators: Anti-Drug Antibodies (ADA) [ Time Frame: Day 1, Day 15, Day 29, Day 43, Day 57, Day 85 and 30 Days After Last Dose, up to 52 weeks ]Number of Participants who Develop Antidrug Antibodies to AB154 and/or AB122
- Overall Response Rate [ Time Frame: First Dose Date to Progression or Last Tumor Assessment, up to 1 year ]Number of Participants with Complete or Partial Response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.1
- Duration of Response [ Time Frame: Start Date of Response to First Progression/Death, up to 1 year ]Time at Which Response Criteria are Met for Complete Response or Partial Response (Whichever Occurs First) Until the First Date of Recurrence, Progression or Death per RECIST v1.1
- Disease Control Rate [ Time Frame: First Dose Date to First Progression/Death, up to 1 year ]Number of Participants with Complete Response, Partial Response, or Stable Disease for Greater Than 6 Months per RECIST v1.1
- Progression Free Survival [ Time Frame: First Dose Date to First Progression/Death, up to 1 year ]Number of Participants Without Disease Progression per RECIST v1.1
- Overall Survival [ Time Frame: First Dose Date to Date of Death, up to 1 year ]Overall Survival Rate, Defined as Time Between First Dose Date and Date of Death

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Capable of giving signed informed consent
- Male or female participants ≥ 18 years of age at the time of screening
- Negative serum pregnancy test at screening and prior to dosing on Cycle 1 Day 1; negative serum or urine pregnancy test on the first day of each subsequent treatment period
- Pathologically confirmed non-small cell lung cancer, squamous cell carcinoma of the head and neck, renal cell carcinoma, breast cancer, colorectal cancer, melanoma, bladder cancer, ovarian cancer, endometrial cancer, Merkel cell carcinoma, or gastroesophageal cancer that is metastatic, advanced, or recurrent with progression for which no alternative or curative therapy exists or standard therapy is not considered appropriate by the participant and treating physician
- 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
- Must have received standard of care, including potentially curative available therapies or interventions
- Confirmation that an archival tissue sample is available and ≤ 6 months old; if not, a new biopsy of a tumor must be obtained
- Prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) or biologic agents must have been completed at least 4 weeks before investigational product administration, and all AEs have either returned to baseline or stabilized
- 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 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:
- Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
- Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational product hazardous (eg, interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms)
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628677
Contact: Medical Director | 510-694-6200 | ClinicalTrialInquiry@arcusbio.com |
Australia, New South Whales | |
Scientia Clinical Research | Recruiting |
Randwick, New South Whales, Australia, 2031 | |
Contact: James Kuo, MD | |
Principal Investigator: James Kuo, MD |
Study Director: | Medical Director | Arcus Biosciences, Inc. |
Responsible Party: | Arcus Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT03628677 History of Changes |
Other Study ID Numbers: |
AB154CSP0001 |
First Posted: | August 14, 2018 Key Record Dates |
Last Update Posted: | October 1, 2018 |
Last Verified: | September 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Carcinoma, Squamous Cell Urinary Bladder Neoplasms Carcinoma, Renal Cell Endometrial Neoplasms Head and Neck Neoplasms Carcinoma, Merkel Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplasms, Squamous Cell Urologic Neoplasms |