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

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Performance status score of 0 or 1
  • Measurable disease as per radiographic evaluation
  • Disease-specific criteria for dose escalation:
    • Participants with any type of solid tumor for which no treatment is currently available, or
    • Participants with non-Hodgkin Lymphoma that has progressed on prior chemotherapy and unable to receive stem cell transplant or adoptive cell transfer
    • Participants may have received up to 5 prior anti-cancer therapies and an unlimited number of prior hormonal therapies.
  • Disease-specific criteria for dose-expansion Cohort 1:
    • Participants with previously untreated locally advanced or metastatic NSCLC with a high PD-L1 expression
  • Disease-specific criteria for dose-expansion Cohort 2:
    • Participants with metastatic melanoma with at least one prior anti-cancer therapy and progression after PD-L1 therapy
  • Disease-specific criteria for dose-expansion Cohort 3:
    • Participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer with at least 1 prior chemotherapy and no prior PD-(L)1 therapy.
  • Disease-specific criteria for dose-expansion Cohort 4:
    • Participants with metastatic cervical cancer with at least 1 prior chemotherapy and no prior PD-(L)1 therapy.
  • Disease-specific criteria for dose-expansion Cohort 5:
    • Participants with diffuse large B-cell lymphoma (DLBCL) with at least 2 prior anti-cancer therapies and unable to receive stem cell transplant or adoptive cell transfer, or
    • Participants with multiple myeloma with at least 3 prior anti-cancer therapies and for whom no treatment is currently available.

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

Additional Trial Information

Phase 1

Enrollment: 107 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting

California

UCLA Jonsson Comprehensive Cancer Center University of California Los Angeles

Los Angeles, CA

Open and Accepting

Colorado

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Not Yet Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting

Advent Health Cancer Institute (Orlando)

Orlando, FL

Not Yet Accepting

Indiana

Goshen Hospital IU Health

Goshen, IN

Open and Accepting

Iowa

Holden Comprehensive Cancer Center University of Iowa Hospitals and Clinics

Iowa City, IA

Not Yet Accepting

Kentucky

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Not Yet Accepting

Michigan

Henry Ford Medical Center (Columbus)

Novi, MI

Not Yet Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

New York

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, NY

Open and Accepting

Ohio

The Ohio State University Comprehensive Cancer Center The James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting

Oklahoma

University of Oklahoma Health Sciences Center

Oklahoma City, OK

Open and Accepting

Pennsylvania

UPMC Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)

Pittsburgh, PA

Open and Accepting

Tennessee

Tennessee Oncology Centennial Clinic

Nashville, TN

Open and Accepting

Texas

The START Center - San Antonio South Texas Accelerated Research Therapeutics

San Antonio, TX

Open and Accepting

Utah

START South Texas Accelerated Research Therapeutics Mountain Region

West Valley City, UT

Open and Accepting

Virginia

Virginia Cancer Specialists

Fairfax, VA

Open and Accepting

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

Open and Accepting
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