Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03628677
Other study ID # AB154CSP0001
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date September 12, 2018
Est. completion date November 2024

Study information

Verified date May 2024
Source Arcus Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 1, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, PK, PD, and clinical activity of domvanalimab (AB154) as monotherapy and in combination with zimberelimab (AB122) in participants with advanced solid malignancies.


Description:

This is a Phase 1, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, PK, PD, and clinical activity of domvanalimab as monotherapy and in combination with zimberelimab in participants with advanced solid malignancies. In this dose escalation study, participants will receive domvanalimab administered intravenously as monotherapy or in combination with zimberelimab. Treatment will continue until progressive disease, unacceptable toxicity, withdrawal of consent, or other reasons for study drug discontinuation occurs.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 75
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - Participants with any pathologically confirmed solid tumor type for which no standard of care therapy exists - 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 7. Confirmation that an archival tissue sample is available and = 6 months old; if not, a new biopsy of a tumor must be obtained 8. 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 - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 100 days after the last dose of domvanalimab as monotherapy and in combination with zimberelimab. - Participants who require a Legally Authorized Representative (LAR) to provide informed consent on their behalf. - 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 - Has had prior chemotherapy, targeted small-molecule therapy, immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer), biologic agents or radiation therapy within 4 weeks (or 5 half-lives) prior to Day 1 or has not recovered from AEs due to a previously administered agent - Use of other investigational drugs within 28 days or at least 5 half-lives before investigational product administration.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Domvanalimab
Domvanalimabis a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT
Zimberelimab
Zimbererlimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1

Locations

Country Name City State
Australia Albury, Australia Albury New South Wales
Australia Principal Investigator Camperdown New South Wales
Australia The Kinghorn Cancer Centre Darlinghurst New South Wales
Australia Olivia Newton-John Cancer Research Institute Heidelberg Victoria
Australia Scientia Clinical Research Randwick New South Wales
Australia Principal Investigator South Brisbane Queensland
Australia Principal Investigator Tweed Heads New South Wales
United States MD Anderson Cancer Center Houston Texas
United States Carolina BioOncology Institute Huntersville North Carolina
United States The Angeles Clinic and Research Institute Los Angeles California
United States START San Antonio Texas
United States Medical Oncology Associates, PS (dba Summit Cancer Centers) Spokane Washington

Sponsors (2)

Lead Sponsor Collaborator
Arcus Biosciences, Inc. Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other Domvanalimab Receptor Occupancy Receptor Occupancy May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 141 and 30 Days After Last Dose, up to 52 weeks
Other Domvanalimab Immunophenotyping Immunophenotyping May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 141 and 30 Days After Last Dose, up to 52 weeks
Other Domvanalimab Gene Expression Gene Expression May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 141 and 30 Days After Last Dose, up to 52 weeks
Other Domvanalimab Cytokines Cytokines May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples. Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 141 and 30 Days After Last Dose, up to 52 weeks
Other .Zimberelimab Receptor Occupancy Receptor Occupancy May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 141 and 30 Days After Last Dose, up to 52 weeks
Other Zimberelimab Immunophenotyping Immunophenotyping May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 141 and 30 Days After Last Dose, up to 52 weeks
Other Zimberelimab Cytokines Cytokines May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples : Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 141 and 30 Days After Last Dose, up to 52 weeks
Other Zimberelimab Gene Expression Gene Expression May be Summarized by Dose Group and Subject Over Time by Aggregating Data From Exploratory Biomarkers Collected From Peripheral Blood Samples Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 141, and 30 Days After Last Dose, up to 52 weeks
Primary Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 Number of Participants Treated with domvanalimab or domvanalimab in Combination with zimberelimab with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 From First Dose Date to 100 Days After Last Dose
Secondary AB154 Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax) of domvanalimab Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Secondary Zimberelimab Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax) of zimberelimab Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Secondary Domvanalimab Time of Peak Concentration (Tmax) Time of Peak Concentration (Tmax) of domvanalimab Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Secondary Zimberelimab Time of Peak Concentration (Tmax) Time of Peak Concentration (Tmax) of zimberelimab Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Secondary Domvanalimab Area Under the Plasma Concentration Versus Time Curve (AUC) Area Under the Plasma Concentration Versus Time Curve (AUC) of domvanalimab Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Secondary Zimberelimab Area Under the Plasma Concentration Versus Time Curve (AUC) Area Under the Plasma Concentration Versus Time Curve (AUC) of zimberelimab Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Secondary Immunogenicity Indicators: Anti-Drug Antibodies (ADA) Number of Participants who Develop Antidrug Antibodies to AB154 and/or AB122 Day 1, Day 15, Day 29, Day 43, Day 57, Day 85 and 30 Days After Last Dose, up to 52 weeks
Secondary Overall Response Rate Number of Participants with Complete or Partial Response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.1 First Dose Date to Progression or Last Tumor Assessment, up to 1 year
Secondary Duration of Response 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 Start Date of Response to First Progression/Death, up to 1 year
Secondary Disease Control Rate Number of Participants with Complete Response, Partial Response, or Stable Disease for Greater Than 6 Months per RECIST v1.1 First Dose Date to First Progression/Death, up to 1 year
Secondary Progression Free Survival Number of Participants Without Disease Progression per RECIST v1.1 First Dose Date to First Progression/Death, up to 1 year
Secondary Overall Survival Overall Survival Rate, Defined as Time Between First Dose Date and Date of Death First Dose Date to Date of Death, up to 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05723640 - The Safety and Dosimetry Study of 177Lu-LNC1004 Injection Phase 1
Completed NCT04976803 - Tissue Collection for Correlation Between ATM Alterations by Next-Generation Sequencing and ATM Loss-of-Protein
Recruiting NCT04932525 - Gustave Roussy Cancer Profiling Phase 1
Recruiting NCT04643418 - Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04443088 - An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors Phase 1
Recruiting NCT04942717 - Adapting for Latinx Populations an Intervention That Involves Discussing and Sharing Patients' Health-Related Values
Recruiting NCT04169321 - Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors Phase 1
Recruiting NCT05695638 - Proseq Cancer: Genomic Profiling in Patients With Incurable Cancer in Search for Targeted Treatment
Completed NCT03318445 - Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair Phase 1
Recruiting NCT04537936 - Psychotherapy Intervention for Latinos With Adv Cancer N/A
Completed NCT04252339 - RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors Phase 1
Active, not recruiting NCT04577963 - A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06136065 - 68 Gallium-Fibroblast Activating Protein Inhibitors-46 Positron Emission Tomography - Computerized Tomography for Molecular Assessment of Fibroblast Activation and Risk Assessment in Solid Tumors Phase 2
Recruiting NCT04015609 - Psychotherapy Intervention for Latinos With Advanced Cancer N/A
Available NCT04100694 - Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor