A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies

NCT ID: NCT03628677

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-12
• Study Completion Date: 2025-01-23

Brief 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.

Conditions

Solid Tumor, Unspecified, Adult

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Domvanalimab Monotherapy

Varying Doses of domvanalimab Monotherapy

Group Type: EXPERIMENTAL

Domvanalimab

Intervention Type: DRUG

Domvanalimabis a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT

Domvanalimab + zimberelimab Q2W Combination Therapy

Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab

Group Type: EXPERIMENTAL

Domvanalimab

Intervention Type: DRUG

Domvanalimabis a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT

Zimberelimab

Intervention Type: DRUG

Zimbererlimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1

Domvanalimab + zimberelimab Q3W Combination Therapy

Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab

Group Type: EXPERIMENTAL

Domvanalimab

Intervention Type: DRUG

Domvanalimabis a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT

Zimberelimab

Intervention Type: DRUG

Zimbererlimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1

Domvanalimab + zimberelimab Q4W Combination Therapy

Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab

Group Type: EXPERIMENTAL

Domvanalimab

Intervention Type: DRUG

Domvanalimabis a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT

Zimberelimab

Intervention Type: DRUG

Zimbererlimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1

Domvanalimab and Zimberelimab Q6W combination therapy

Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab

Group Type: EXPERIMENTAL

Domvanalimab

Intervention Type: DRUG

Domvanalimabis a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT

Zimberelimab

Intervention Type: DRUG

Zimbererlimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1

Fixed dose Domvanalimab Q3W or Q4W and Zimberelimab Q3W, Q4W

Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab

Group Type: EXPERIMENTAL

Domvanalimab

Intervention Type: DRUG

Domvanalimabis a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT

Zimberelimab

Intervention Type: DRUG

Zimbererlimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1

Interventions

Domvanalimab

Domvanalimabis a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT

Intervention Type: DRUG

Zimberelimab

Zimbererlimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1

Intervention Type: DRUG

Other Intervention Names

AB154; AB122

Eligibility Criteria

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 120 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Arcus Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Arcus Biosciences, Inc.

Locations

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Affinity Health-Hope and Healing Cancer Services, LLC

Hinsdale, Illinois, United States

Carolina BioOncology Institute

Huntersville, North Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

START

San Antonio, Texas, United States

Medical Oncology Associates, PS (dba Summit Cancer Centers)

Spokane, Washington, United States

The Kinghorn Cancer Centre - St Vincent Public Hospital

Darlinghurst, New South Wales, Australia

Tweed Hospital

Tweed Heads, New South Wales, Australia

Icon Cancer Care Brisbane

South Brisbane, Queensland, Australia

Olivia Newton-John Cancer Research Institute-Austin Hostipal

Heidelberg, Victoria, Australia

Countries

United States; Australia

Related Links

https://trials.arcusbio.com/study/?id=AB154CSP0001

AB154CSP0001 - Public Website

Other Identifiers

AB154CSP0001

Identifier Type: -

Identifier Source: org_study_id