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Advanced Solid TumorsPhase 1NCT04087018

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

A Phase 1 study testing zimberelimab in people with Advanced Solid Tumors, run by Arcus Biosciences, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
zimberelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
9 sitesUnited States
Study dates
24 Sep 2019to 17 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Kaiser Permanente Mid-Atlantic

    Gaithersburg, Maryland, 20879

  • Prisma Health

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Christiana Care Health System - Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • Southern California Permanente Medical Group

    Riverside, California, 92120

  • Kaiser Permanente (NorCal) - Roseville

    Roseville, California, 95661

  • Metro MN CCOP

    Saint Louis Park, Minnesota, 55416

Other trials in United States

About this study

Official title: A Phase 1b Study to Evaluate the Safety and Clinical Activity of AB122 in Biomarker-Selected Participants With Advanced Solid Tumors

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.

Read the detailed description

The activity of zimberelimab every 3 weeks (Q3W) will be evaluated in molecularly defined patient populations as described by the StrataNGS test (to be performed outside of this study protocol). Participants with any advanced tumor type will be stratified evenly by tumor biomarker status as follows: TMB-H or Strata Immune Signature positive. Each cohort may enroll approximately 40 participants. Following completion of and/or discontinuation from investigational product and follow-up, all participants will be followed for survival.

Being tested
zimberelimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zimberelimabDrug

    Also called AB122

    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.

Study groups in NCT04087018
Study groupRoleWhat they receive
TMB-HExperimentalParticipants with a tumor biomarker status of TMB-H will receive zimberelimab every 3 weeks.
Receives: Drug: zimberelimab
Strata Immune Signature positiveExperimentalParticipants with a tumor biomarker status Strata Immune Signature positive will receive zimberelimab every 3 weeks.
Receives: Drug: zimberelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Approximately 12 months

Secondary outcomes (7)

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

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

    Measured: 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

  2. Duration of response (DoR)

    The time from first documentation of disease response (CR or PR) until first documentation of progressive disease.

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

  3. Time to response (TTR)

    The time from treatment initiation to confirmed best overall response of CR or PR.

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

  4. Disease control rate at 6 months (DCR6)

    Number of Participants with Complete Response, Partial Response, or Stable Disease for Greater Than 6 Months per RECIST v1.1

    Measured: 6 Months

  5. Progression-free survival at 6 (PFS6)

    The percentage of Participants Without Disease Progression per RECIST v1.1 and iRECIST at 6 months

    Measured: 6 Months

  6. Progression-free survival at 12 months (PFS12)

    The percentage of Participants Without Disease Progression per RECIST v1.1 and iRECIST at 12 months

    Measured: 12 Months

  7. Overall survival at 12 months (OS12)

    The percentage of participants who are alive at 12 months based on first dose to date of death.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2019
  2. Study start24 Sep 2019
  3. Primary completion17 Jun 2024
  4. Study completion17 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04087018
Sponsor's protocol ID
AB122CSP0002
Status last verified
May 2024
First submitted
29 Aug 2019
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing zimberelimab in people with Advanced Solid Tumors, run by Arcus Biosciences, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response Rate (ORR) (time frame: Approximately 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04087018.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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