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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05891171
Other study ID # ARC-25
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 13, 2023
Est. completion date August 2025

Study information

Verified date May 2024
Source Arcus Biosciences, Inc.
Contact Medical Director
Phone 1-888-44-ARCUS
Email ClinicalTrials@arcusbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 81
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
AB598
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Carboplatin
Administered as specified in the treatment arm
Pemetrexed
Administered as specified in the treatment arm
Fluorouracil
Administered as specified in the treatment arm
Leucovorin
Administered as specified in the treatment arm
Oxaliplatin
Administered as specified in the treatment arm

Locations

Country Name City State
Australia Queen Elizabeth Hospital Adelaide
United States Gabrail Cancer Center Canton Ohio
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Next Oncology Dallas Dallas Texas
United States Karmanos Cancer Institute Detroit Michigan
United States Next Oncology Virginia Fairfax Virginia
United States Goshen Center for Cancer Care Goshen Indiana
United States Affinity Health-Hope and Healing Cancer Services, LLC Hinsdale Illinois
United States Lake City Cancer Care, LLC. Lake City Florida
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Arcus Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to 2 years
Primary Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs) Up to 2 years
Secondary 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
Secondary Maximum Concentration (Cmax) in Whole Blood and Plasma Predose, Up to 4 hours postdose
Secondary Time to Maximum Concentration (Tmax) in Whole Blood and Plasma Predose, Up to 4 hours postdose
Secondary Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598 Up to 2 years
Secondary Objective Response Rate (ORR) Up to 2 years
Secondary Dose Expansion Cohorts: Duration of Response (DOR) Up to 2 years
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