A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors (ARC-20)

May 28, 2026 updated by: Arcus Biosciences, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

362

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Camperdown, Australia
        • Not yet recruiting
        • Research Site
      • Melbourne, Australia
        • Not yet recruiting
        • Research Site
      • Sydney, Australia
        • Recruiting
        • Research Site
  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Research Site
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • Research Site
    • California
      • San Diego, California, United States, 92093
        • Recruiting
        • Research Site
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Research Site
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Recruiting
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Research Site
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • Research Site
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Research Site
      • New York, New York, United States, 10029
        • Recruiting
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Research Site
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Research Site
      • Nashville, Tennessee, United States, 37240
        • Recruiting
        • Research Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Must have at least one measurable lesion per RECIST guidance
  • Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1

  • Disease-specific criteria for dose escalation:

    • Participants may have any pathologically confirmed solid tumor type where no other treatment options are available
    • Creatinine clearance ≥ 40 mL/min

Disease-specific criteria for dose-expansion:

  • Histologically confirmed ccRCC
  • Creatinine clearance ≥ 40 mL/min

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)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation Cohort 1
Participants will receive casdatifan orally once daily
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Escalation Cohort 2
Participants will receive casdatifan orally once daily
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Escalation Cohort 3
Participants will receive casdatifan orally twice daily
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Expansion Cohort 1
Participants will receive casdatifan orally
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Expansion Cohort 2
Participants will receive casdatifan orally
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Expansion Cohort 3
Participants will receive casdatifan orally
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Escalation Cohort 4
Participants will receive casdatifan orally once daily
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Escalation Cohort 5
Participants will receive casdatifan orally once daily
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Expansion Cohort 4
Participants will receive casdatifan orally with with cabozantinib orally
Drug: Cabozantinib
Administered as specified in the treatment arm
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Expansion Cohort 5
Participants will receive casdatifan orally
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Expansion Cohort 6
Participants will receive casdatifan orally
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Expansion Cohort 7
Participants will receive casdatifan orally with zimberelimab infusion
Drug: Zimberelimab
Administered as specified in the treatment arm
Other Names:
  • AB122
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Expansion Cohort 8
Participants will receive casdatifan orally
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Experimental: Dose Expansion Cohort 9
Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion
Drug: Zimberelimab
Administered as specified in the treatment arm
Other Names:
  • AB122
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Drug: Ipilimumab
Administered as specified in the treatment arm
Experimental: Dose Expansion Cohort 10
Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion
Drug: Zimberelimab
Administered as specified in the treatment arm
Other Names:
  • AB122
Drug: casdatifan
Administered as specified in the treatment arm
Other Names:
  • AB521
Drug: Ipilimumab
Administered as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with dose limiting toxicities (DLTs)
Time Frame: Up to 4 months
Up to 4 months
Number of participants with adverse events (AEs)
Time Frame: Up to 4 months
Up to 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: Up to 4 months
Up to 4 months
Plasma concentration of casdatifan
Time Frame: Up to 4 months
Up to 4 months
Area under the plasma concentration time curve (AUC) of casdatifan
Time Frame: Up to 4 months
Up to 4 months
Maximum Observed Plasma Concentration (Cmax) of casdatifan
Time Frame: Up to 4 months
Up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arcus Biosciences, Inc.

Investigators

  • Study Director: Medical Director, Arcus Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2022

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC-20
  • 2024-519142-70-00 (Ctis)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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