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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04772989
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Arcus Biosciences, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director
Principal Investigator Affiliation Arcus Biosciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Poland, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Solid Tumor, NSCLC, Melanoma, Cervical Cancer, Multiple Myeloma, Lymphoma, Non-Hodgkin, DLBCL, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer
Arms & Interventions

Arms

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.

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.

Experimental: Dose Escalation Q6W Cohort

Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.

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.

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.

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.

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.

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.

Interventions

Drug: - AB308

Administered intravenously (IV) as specified in the treatment arm

Drug: - Zimberelimab

Administered IV as specified in the treatment arm

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Recruiting

Address

Mayo Clinic Arizona - Mayo Clinic Hospital

Phoenix, Arizona, 85054-4502

University of California, Los Angeles, Los Angeles, California

Status

Recruiting

Address

University of California, Los Angeles

Los Angeles, California, 90095

Aurora, Colorado

Status

Not yet recruiting

Address

University of Colorado - Cancer Center - PPDS

Aurora, Colorado, 80045-2545

Mayo Clinic Jacksonville - PPDS, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic Jacksonville - PPDS

Jacksonville, Florida, 32224

AdventHealth Orlando, Orlando, Florida

Status

Not yet recruiting

Address

AdventHealth Orlando

Orlando, Florida, 43210

Augusta, Georgia

Status

Not yet recruiting

Address

Augusta Oncology Associates - Wheeler Road

Augusta, Georgia, 30909-6520

Goshen Health System, Goshen, Indiana

Status

Recruiting

Address

Goshen Health System

Goshen, Indiana, 46526

Holden Comprehensive Cancer Center, Iowa City, Iowa

Status

Not yet recruiting

Address

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

Norton Cancer Institute-Downtown, Louisville, Kentucky

Status

Not yet recruiting

Address

Norton Cancer Institute-Downtown

Louisville, Kentucky, 40202

Henry Ford Health System, Novi, Michigan

Status

Not yet recruiting

Address

Henry Ford Health System

Novi, Michigan, 48377

Mayo Clinic - PPDS, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic - PPDS

Rochester, Minnesota, 55905

Columbia University Medical Center, New York, New York

Status

Recruiting

Address

Columbia University Medical Center

New York, New York, 10032-3729

Ohio State University, Columbus, Ohio

Status

Recruiting

Address

Ohio State University

Columbus, Ohio, 43210

Oklahoma City, Oklahoma

Status

Recruiting

Address

University of Oklahoma Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15240

Tennessee Onocology - Nashville, Nashville, Tennessee

Status

Recruiting

Address

Tennessee Onocology - Nashville

Nashville, Tennessee, 37205

San Antonio, Texas

Status

Recruiting

Address

START South Texas Accelerated Research Therapeutics - San Antonio

San Antonio, Texas, 78229

West Valley City, Utah

Status

Recruiting

Address

START South Texas Accelerated Research Therapeutics - Mountain Region

West Valley City, Utah, 84119

Virginia Cancer Specialists, Fairfax, Virginia

Status

Recruiting

Address

Virginia Cancer Specialists

Fairfax, Virginia, 22033-1712

University of Wisconsin - Madison, Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin - Madison

Madison, Wisconsin, 53792

International Sites

Jagiellonskie Centrum Innowacji, Kraków, Poland

Status

Recruiting

Address

Jagiellonskie Centrum Innowacji

Kraków, ,

Lubin, Poland

Status

Recruiting

Address

Specjalistyczna Praktyka Lekarska Slawomir Mandziuk

Lubin, ,

Olsztyn, Poland

Status

Recruiting

Address

SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

Olsztyn, ,

Med-Polonia Sp. z o.o., Poznań, Poland

Status

Recruiting

Address

Med-Polonia Sp. z o.o.

Poznań, ,

Narodowy Instytut Onkologii, Warszawa, Poland

Status

Recruiting

Address

Narodowy Instytut Onkologii

Warszawa, ,

Hospital Universitario Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitario Vall d'Hebron

Barcelona, ,

Clínica Universidad de Navarra, Madrid, Spain

Status

Recruiting

Address

Clínica Universidad de Navarra

Madrid, ,

Madrid, Spain

Status

Recruiting

Address

START MADRID_Hospital Universitario HM Sanchinarro - CIOCC

Madrid, ,