Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors

NCT04087018 | Completed Phase 1 FDA Drug

• 1 other identifier: AB122CSP0002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 9

Brief Summary

This is a Phase 1b open-label study to evaluate the safety and clinical activity of zimberelimab (AB122) in biomarker-selected participants with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Objective response Rate (ORR)

  Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Tumor assessments over time will be measured using RECIST v1.1

  Approximately 12 months

Secondary Outcomes (7)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0

  From screening until 90 days after the last dose of investigational product or until initiation of a new systemic anticancer therapy, whichever occurs first, approximately 12 months

• Duration of response (DoR)

  From the date of initiation of treatment until the date of first documented progression, through completion of the study, approximately 12 months

• Time to response (TTR)

  From the date of initiation of treatment until the date of first documented response, through completion of the study, approximately 12 months

• Disease control rate at 6 months (DCR6)

  6 Months

• Progression-free survival at 6 (PFS6)

  6 Months

Study Arms (2)

TMB-H

EXPERIMENTAL

Participants with a tumor biomarker status of TMB-H will receive zimberelimab every 3 weeks.

Drug: zimberelimab

Strata Immune Signature positive

EXPERIMENTAL

Participants with a tumor biomarker status Strata Immune Signature positive will receive zimberelimab every 3 weeks.

Drug: zimberelimab

Interventions

zimberelimab DRUG

zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1. Participants in each cohort will receive zimberelimab intravenously Q3W. Treatment will continue until progressive disease, unacceptable toxicity, withdrawal of consent, or other reasons for which investigational product discontinuation occurs.

Also known as: AB122

Strata Immune Signature positive; TMB-H

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 negative serum or urine pregnancy test every 3 months during the treatment period (women of childbearing potential only).
• Pathologically confirmed tumor that is metastatic, advanced, or recurrent with progression for which no alternative known to improve survival or curative therapy exists. Tumors must be TMB-H or Strata Immune Signature positive.
• Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 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.
• Prior chemotherapy or certain immune therapies or biologic agents must have been completed at least 4 weeks (28 days) before investigational product administration and all AEs have either returned to baseline or stabilized.
• Previously treated brain or meningeal metastases with no evidence of progression by magnetic resonance imaging (MRI) for at least 4 weeks (28 days) prior to the first dose.
• 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

You may not qualify if:

• Use of any live attenuated vaccines against infectious diseases 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 or obscure the interpretation of toxicity determination or Adverse events (AEs).
• History of myocardial infarction within 6 months or history of arterial thromboembolic event within 3 months of the first dose of investigational agent.
• 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 90 days after the last dose of investigational product.
• Any active or documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications.
• Any acute gastrointestinal symptoms at the time of screening or admission.
• Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
• Prior treatment with an anti-PD-L1 or anti-PD-1 as monotherapy or in combination.
• Prior treatment with temozolomide.
• Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before investigational product administration.

Sponsors & Collaborators

• Arcus Biosciences, Inc.: lead
• Strata Oncology: collaborator
• Gilead Sciences: collaborator

Study Sites (9)

Southern California Permanente Medical Group

Riverside, California, 92120, United States

Location

Kaiser Permanente (NorCal) - Roseville

Roseville, California, 95661, United States

Location

Christiana Care Health System - Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Kaiser Permanente Mid-Atlantic

Gaithersburg, Maryland, 20879, United States

Location

Metro MN CCOP

Saint Louis Park, Minnesota, 55416, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Related Links

• AB122CSP0002 - Public website

MeSH Terms

Interventions

zimberelimab

Study Officials

• Medical Director

  Arcus Biosciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 12, 2019
• Study Start: September 24, 2019
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (9)