Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

Ovarian Cancer Clinical Trial

— ARC-25  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891171
• Other study ID #: ARC-25
• Status: Recruiting
• Phase: Phase 1
• Start date: October 13, 2023
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Arcus Biosciences, Inc.
• Contact: Medical Director
• Phone: +1-510-462-3330
• Email: ClinicalTrials[@]arcusbio.com
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Advanced Cancer
• Advanced Malignancies
• Bladder Cancer
• Carcinoma
• Carcinoma, Renal Cell
• Cervical Cancer
• Esophageal Cancer
• Gastric Cancer
• Head and Neck Squamous Cell Carcinoma (HNSCC)
• Neoplasms
• Non-Small Cell Lung Cancer (NSCLC)
• Ovarian Cancer
• Renal Cell Carcinoma (RCC)
• Squamous Cell Carcinoma of Head and Neck
• Triple Negative Breast Cancer (TNBC)
• Triple Negative Breast Neoplasms

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