A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies (ARC-12)

March 27, 2024 updated by: Arcus Biosciences, Inc.

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies

This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Kraków, Poland
        • Jagiellonskie Centrum Innowacji
      • Lubin, Poland
        • Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
      • Olsztyn, Poland
        • SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
      • Poznań, Poland
        • Med-Polonia Sp. z o.o.
      • Warszawa, Poland
        • Narodowy Instytut Onkologii
  • Spain
      • Barcelona, Spain
        • Hospital Universitario Vall d'Hebron
      • Madrid, Spain
        • Clinica Universidad de Navarra
      • Madrid, Spain
        • START MADRID_Hospital Universitario HM Sanchinarro - CIOCC
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054-4502
        • Mayo Clinic Arizona - Mayo Clinic Hospital
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
    • Colorado
      • Aurora, Colorado, United States, 80045-2545
        • University of Colorado - Cancer Center - PPDS
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville - PPDS
      • Orlando, Florida, United States, 43210
        • AdventHealth Orlando
    • Georgia
      • Augusta, Georgia, United States, 30909-6520
        • Augusta Oncology Associates - Wheeler Road
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Goshen Health System
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Holden Comprehensive Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute-Downtown
    • Michigan
      • Novi, Michigan, United States, 48377
        • Henry Ford Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - PPDS
    • New York
      • New York, New York, United States, 10032-3729
        • Columbia University Medical Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Peggy and Charles Stephenson Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Tennessee Onocology - Nashville
    • Texas
      • San Antonio, Texas, United States, 78229
        • START South Texas Accelerated Research Therapeutics - San Antonio
    • Utah
      • West Valley City, Utah, United States, 84119
        • START South Texas Accelerated Research Therapeutics - Mountain Region
    • Virginia
      • Fairfax, Virginia, United States, 22033-1712
        • Virginia Cancer Specialists
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Male or female participants ≥ 18 years of age (or age ≥ regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Adequate organ and marrow function

Exclusion Criteria:

  • History of trauma or major surgery within 28 days prior to the first dose of study treatment.
  • Prior treatment with an anti-TIGIT antibody.
  • Any active or prior autoimmune disease that required treatment within 3 years of the first dose of study treatment.
  • Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic agents, or use of other investigational drugs within 28 days before first dose of study treatment.
  • Discontinued prior immunotherapy for immune related adverse events with a high severity.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation Q3W Cohorts
Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies.
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
  • AB122
Experimental: Dose Escalation Q4W Cohorts
Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies.
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
  • AB122
Experimental: Dose Escalation Q6W Cohort
Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
  • AB122
Experimental: Dose Expansion Cohort 1
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with in participants with locally advanced or metastatic NSCLC.
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
  • AB122
Experimental: Dose Expansion Cohort 2
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma.
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
  • AB122
Experimental: Dose Expansion Cohort 3
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer.
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
  • AB122
Experimental: Dose Expansion Cohort 4
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer.
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
  • AB122
Experimental: Dose Expansion Cohort 5
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies.
Drug: AB308
Administered intravenously (IV) as specified in the treatment arm
Drug: Zimberelimab
Administered IV as specified in the treatment arm
Other Names:
  • AB122

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with Adverse Events
Time Frame: From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
Percentage of participants who experience a Dose Limiting Toxicity
Time Frame: From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)
From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Response
Time Frame: From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months
Time Frame: From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Percentage of participants with Objective Response
Time Frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 3-5 years)
From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 3-5 years)
Serum concentration of AB308
Time Frame: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Serum concentration of zimberelimab
Time Frame: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with anti-drug antibodies to AB308
Time Frame: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with anti-drug antibodies to zimberelimab
Time Frame: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arcus Biosciences, Inc.

Collaborators

Gilead Sciences

Investigators

  • Study Director: Medical Director, Arcus Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2021

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC-12
  • 2021-005589-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe