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

Completed · Phase 1

Conditions studied: Advanced Solid Tumor, Non Small Cell Lung Cancer (NSCLC), Melanoma, Cervical Cancer, Multiple Myeloma, Lymphoma, Non-Hodgkin, Diffuse Large B Cell Lymphoma (DLBCL), Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer

In brief

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.

Key facts

Study ID

NCT04772989

Run by

Arcus Biosciences, Inc.

People needed

94

Starts

2021-03-19

Expected to finish

2025-08-25

Last updated by the study team

2025-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UCLA Department of Medicine - Hematology/Oncology — Los Angeles, California, United States
• Mayo Clinic Jacksonville - PPDS — Jacksonville, Florida, United States
• Goshen Health System — Goshen, Indiana, United States
• Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Norton Cancer Insititute-Downtown — Louisville, Kentucky, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Columbia University Medical Center — New York, New York, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• University of Oklahoma Peggy and Charles Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Tennessee Onocology - Nashville — Nashville, Tennessee, United States
• START South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
• START South Texas Accelerated Research Therapeutics - Mountain Region — West Valley City, Utah, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• University of Wisconsin - Madison — Madison, Wisconsin, United States
• Specjalistyczna Praktyka Lekarska Slawomir Mandziuk — Lubin, Poland
• Med-Polonia Sp. z o.o. — Poznan, Poland
• Hospital Universitario Vall d'Hebron — Barcelona, Spain
• Clínica Universidad de Navarra - Madrid — Madrid, Spain
• Hospital Universitario 12 de Octubre — Madrid, Spain
• START MADRID Hospital Unviersitario Fundacion Jimenez Diaz — Madrid, Spain
• Clínica Universidad de Navarra — Pamplona, Spain

Full record on ClinicalTrials.gov

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