A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors

Solid Tumors Clinical Trial

— ARC-20  

Official title:

A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536141
• Other study ID #: ARC-20
• Status: Recruiting
• Phase: Phase 1
• Start date: October 26, 2022
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: Arcus Biosciences, Inc.
• Contact: Medical Director
• Phone: 1-888-44-ARCUS
• Email: ClinicalTrials[@]arcusbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of:

• AB521 when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and

• AB521 monotherapy and AB521 in combination with cabozantinib in participants with ccRCC in the dose expansion stage

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 302
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Disease-specific criteria for dose escalation:

• Participants may have any pathologically confirmed solid tumor type where no other treatment options are available

• Disease-specific criteria for dose-expansion:

• Histologically confirmed ccRCC

• For AB521 monotherapy cohorts: participants must have received prior treatment in the metastatic setting with an anti-PD-1/PD-L1 therapy and a vascular endothelial growth factor receptor-targeting tyrosine kinase inhibitor (VEGFR-targeting TKI), (either individually or in combination)

• For AB521 + cabozantinib combination therapy: participants must have received prior treatment for locally advanced or metastatic disease with anti-PD-1/PD-L1 therapy in an immediately preceding line of therapy

• Must have at least one measurable lesion per RECIST guidance

• Eastern Cooperative Oncology Group (ECOG) performance status score of = 1

Key Exclusion Criteria:

• Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product

• Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous

• History of trauma or major surgery within 28 days prior to the first dose of investigational product

• For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2a inhibitor. For the AB521 + cabozantinib combination cohort, any prior treatment with cabozantinib

• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma
• Solid Tumors

Intervention

Drug:
• AB521
Administered as specified in the treatment arm
• Cabozantinib
Administered as specified in the treatment arm

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Severance Hospital Cancer Center	Seoul
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Barbara Ann Karmanos Cancer Center	Detroit	Michigan
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Louisville Brown Cancer Center	Louisville	Kentucky
United States	University of Miami	Miami	Florida
United States	Sarah Cannon	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Oschner Health	New Orleans	Louisiana
United States	Tisch Cancer Institute, Mount Sinai Hospital	New York	New York
United States	Nebraska Cancer Specialists - Oncology Hematology West PC	Omaha	Nebraska
United States	South Texas Accelerated Research Therapeutics, LLC	San Antonio	Texas
United States	UCLA	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Arcus Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with dose limiting toxicities (DLTs)		Up to 4 months
Primary	Number of participants with adverse events (AEs)		Up to 4 months
Secondary	Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1		Up to 4 months
Secondary	Plasma concentration of AB521		Up to 4 months
Secondary	Area under the plasma concentration time curve (AUC) of AB521		Up to 4 months
Secondary	Maximum Observed Plasma Concentration (Cmax) of AB521		Up to 4 months