Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers (ARC-25)

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

The primary purpose of this study is to assess the safety and tolerability of AB598 when taken alone, and in combination with zimberelimab and standard chemotherapy in participants with advanced malignancies.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Gastric Cancer; Esophageal Cancer; Ovarian Cancer; Bladder Cancer; Advanced Cancer; Non-Small Cell Lung Cancer (NSCLC); Advanced Malignancies; Renal Cell Carcinoma (RCC); Triple Negative Breast Cancer (TNBC); Head and Neck Squamous Cell Carcinoma (HNSCC); Gastroesophageal-junction Cancer (GEJ)
• Intervention / Treatment: Drug: Oxaliplatin; Drug: Zimberelimab; Drug: Fluorouracil; Drug: Leucovorin; Drug: AB598; Drug: Carboplatin; Drug: Pemetrexed

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Medical Director; Phone Number: +1-510-462-3330; Email: ClinicalTrials@arcusbio.com

Study Locations

• United States
  • Florida
    • Lake City, Florida, United States, 32024
      • Recruiting
      • Lake City Cancer Care, LLC.
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • Recruiting
      • Affinity Health-Hope and Healing Cancer Services, LLC
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Recruiting
      • Goshen Center for Cancer Care
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Institute
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
  • Ohio
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Gabrail Cancer Center
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
  • Texas
    • Dallas, Texas, United States, 75039
      • Recruiting
      • Next Oncology Dallas
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Next Oncology Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

• Monotherapy-specific criteria for dose escalation cohorts:

  • Participants may have any pathologically confirmed advanced or metastatic solid tumor malignancy for which standard therapy has proven ineffective, intolerable, or considered inappropriate

• Disease-specific criteria for dose-expansion Cohort 1 (NSCLC):

  • Histologically confirmed, documented diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC
  • Treatment-naive in the unresectable locally advanced or metastatic setting
  • Cannot have progressed within 6 months of prior platinum-based chemotherapy for earlier stage disease
  • Mixed small-cell lung cancer histology is not permitted

• Disease-specific criteria for dose expansion Cohort 2 (Gastric/GEJ):

  • Histologically confirmed, documented diagnosis of human epidermal growth factor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma
  • No prior systemic treatment for locally advanced unresectable or metastatic disease
  • Cannot have progressed within 6 months of prior platinum-based chemotherapy for earlier stage disease

Key Exclusion Criteria:

• Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study
• Underlying medical conditions or AEs that, in the investigator's or sponsor's opinion, will make the administration of the study drugs hazardous
• Any active or documented history of autoimmune disease including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment
• History of trauma or major surgery within 28 days prior to the first dose of study drug
• Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment with certain protocol specified exceptions

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation Cohort 1; Participants will receive AB598 intravenous (IV) infusion once every 3 weeks	Drug: AB598; Administered as specified in the treatment arm
Experimental: Dose Escalation Cohort 2; Participants will receive AB598 IV infusion once every 3 weeks	Drug: AB598; Administered as specified in the treatment arm
Experimental: Dose Escalation Cohort 3; Participants will receive AB598 IV infusion once every 3 weeks	Drug: AB598; Administered as specified in the treatment arm
Experimental: Dose Escalation Cohort 4; Participants will receive AB598 IV infusion once every 3 weeks	Drug: AB598; Administered as specified in the treatment arm
Experimental: Dose Expansion Cohort 1 NSCLC; Participants will receive AB598 IV infusion in combination with zimberelimab and carboplatin/pemetrexed once every 3 weeks, for up to 2 years	Drug: Zimberelimab; Administered as specified in the treatment arm; Other Names: AB122; Drug: AB598; Administered as specified in the treatment arm; Drug: Carboplatin; Administered as specified in the treatment arm; Drug: Pemetrexed; Administered as specified in the treatment arm
Experimental: Dose Expansion Cohort 2 Gastric/GEJ Cancer; Participants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab once every 4 weeks, and FOLFOX (oxaliplatin, leucovorin, fluorouracil) every 2 weeks, for up to 2 years	Drug: Oxaliplatin; Administered as specified in the treatment arm; Drug: Zimberelimab; Administered as specified in the treatment arm; Other Names: AB122; Drug: Fluorouracil; Administered as specified in the treatment arm; Drug: Leucovorin; Administered as specified in the treatment arm; Drug: AB598; Administered as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to 2 years
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	Up to 2 years
Area Under the Concentration-Time Curve from Administration ("0") to the Time That the Drug is No Longer Present in the Body ("infinity") (AUC 0-inf) in Whole Blood and Plasma	Predose, Up to 4 hours postdose
Maximum Concentration (Cmax) in Whole Blood and Plasma	Predose, Up to 4 hours postdose
Time to Maximum Concentration (Tmax) in Whole Blood and Plasma	Predose, Up to 4 hours postdose
Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598	Up to 2 years
Dose Expansion Cohorts: Duration of Response (DOR)	Up to 2 years

Collaborators and Investigators

• Sponsor: Arcus Biosciences, Inc.
• Investigators: Study Director: Medical Director, Arcus Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Zimberelimab; AB122; AB598
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Head and Neck Neoplasms; Kidney Neoplasms; Carcinoma, Squamous Cell; Breast Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplasms; Carcinoma, Renal Cell; Carcinoma; Squamous Cell Carcinoma of Head and Neck; Triple Negative Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Folic Acid Antagonists; Carboplatin; Fluorouracil; Oxaliplatin; Leucovorin; Pemetrexed
• Other Study ID Numbers: ARC-25

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