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

August 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
362

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Camperdown, Australia
        • Not yet recruiting
        • Research Site
      • Melbourne, Australia
        • Recruiting
        • Research Site
      • Sydney, Australia
        • Recruiting
        • Research Site
  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Research Site
  • Spain
      • Barcelona, Spain
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arcus Biosciences, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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