RecruitingPhase 1NCT05536141

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

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

Sponsor

Arcus Biosciences, Inc.

Enrollment

362 participants

Start Date

Oct 26, 2022

Study Type

INTERVENTIONAL

Conditions

Solid Tumors Clear Cell Renal Cell Carcinoma

Summary

The purpose of this study is to evaluate the safety and tolerability of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 study testing a new drug called AB521, either alone or in combination with other drugs, in patients with kidney cancer (renal cell carcinoma) and other solid tumors. The main goal is to find the safest and most effective dose and to see how patients respond to the treatment. **You may be eligible if:** - You have a solid tumor (any type) with no remaining standard treatment options (for the dose-finding phase) - You have confirmed clear cell renal cell carcinoma (the most common type of kidney cancer) — for the dose-expansion phase - Your tumor is measurable on scans - Your general health is good (ECOG score 0–1) - Your kidney function is adequate (creatinine clearance ≥40 mL/min) **You may NOT be eligible if:** - You received a live vaccine within the past 4 weeks - You have significant heart, lung, or psychiatric conditions that would interfere with participation - You have certain active infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcasdatifan

Administered as specified in the treatment arm

DRUGCabozantinib

Administered as specified in the treatment arm

DRUGZimberelimab

Administered as specified in the treatment arm

DRUGIpilimumab

Administered as specified in the treatment arm

Locations(25)

Research Site

Birmingham, Alabama, United States

Research Site

San Diego, California, United States

Research Site

Santa Monica, California, United States

Research Site

Miami, Florida, United States

Research Site

Atlanta, Georgia, United States

Research Site

Louisville, Kentucky, United States

Research Site

New Orleans, Louisiana, United States

Research Site

Baltimore, Maryland, United States

Research Site

Boston, Massachusetts, United States

Research Site

Detroit, Michigan, United States

Research Site

Detroit, Michigan, United States

Research Site

Omaha, Nebraska, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

Cleveland, Ohio, United States

Research Site

Cleveland, Ohio, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Nashville, Tennessee, United States

Research Site

Nashville, Tennessee, United States

Research Site

San Antonio, Texas, United States

Research Site

Camperdown, Australia

Research Site

Melbourne, Australia

Research Site

Sydney, Australia

Research Site

Seoul, South Korea

Research Site

Barcelona, Spain

View Full Details on ClinicalTrials.gov

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NCT05536141

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