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RecruitingNCT05536141ARC-20Updated Aug 31, 2026

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

A Phase 1 interventional study of casdatifan and Cabozantinib in Clear Cell Renal Cell Carcinoma and Solid Tumors, sponsored by Arcus Biosciences, Inc.. Recruiting at 25 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Arcus Biosciences, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
362
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Clear Cell Renal Cell Carcinoma
  • Solid Tumors

Keywords

  • Clear Cell Renal Cell Carcinoma
  • AB521
  • Casdatifan
  • Kidney Cancer
  • Zimberelimab
  • AB122
  • Hif2a
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
362 participants (estimated)

Study arms

  • Experimental
    Dose Escalation Cohort 1

    Participants will receive casdatifan orally once daily

    Drug: casdatifan

  • Experimental
    Dose Escalation Cohort 2

    Participants will receive casdatifan orally once daily

    Drug: casdatifan

  • Experimental
    Dose Escalation Cohort 3

    Participants will receive casdatifan orally twice daily

    Drug: casdatifan

  • Experimental
    Dose Escalation Cohort 4

    Participants will receive casdatifan orally once daily

    Drug: casdatifan

  • Experimental
    Dose Escalation Cohort 5

    Participants will receive casdatifan orally once daily

    Drug: casdatifan

  • Experimental
    Dose Expansion Cohort 1

    Participants will receive casdatifan orally

    Drug: casdatifan

  • Experimental
    Dose Expansion Cohort 2

    Participants will receive casdatifan orally

    Drug: casdatifan

  • Experimental
    Dose Expansion Cohort 3

    Participants will receive casdatifan orally

    Drug: casdatifan

  • Experimental
    Dose Expansion Cohort 4

    Participants will receive casdatifan orally with with cabozantinib orally

    Drug: casdatifan · Drug: Cabozantinib

  • Experimental
    Dose Expansion Cohort 5

    Participants will receive casdatifan orally

    Drug: casdatifan

  • Experimental
    Dose Expansion Cohort 6

    Participants will receive casdatifan orally

    Drug: casdatifan

  • Experimental
    Dose Expansion Cohort 7

    Participants will receive casdatifan orally with zimberelimab infusion

    Drug: casdatifan · Drug: Zimberelimab

  • Experimental
    Dose Expansion Cohort 8

    Participants will receive casdatifan orally

    Drug: casdatifan

  • Experimental
    Dose Expansion Cohort 9

    Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion

    Drug: casdatifan · Drug: Zimberelimab · Drug: Ipilimumab

  • Experimental
    Dose Expansion Cohort 10

    Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion

    Drug: casdatifan · Drug: Zimberelimab · Drug: Ipilimumab

Interventions

  • Drugcasdatifan

    Administered as specified in the treatment arm

    Also known as: AB521

  • DrugCabozantinib

    Administered as specified in the treatment arm

  • DrugZimberelimab

    Administered as specified in the treatment arm

    Also known as: AB122

  • DrugIpilimumab

    Administered as specified in the treatment arm

05

What researchers measure

Primary outcomes

  1. Number of participants with dose limiting toxicities (DLTs)

    Time frame: Up to 4 months

  2. Number of participants with adverse events (AEs)

    Time frame: Up to 4 months

Secondary outcomes

  1. Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: Up to 4 months

  2. Plasma concentration of casdatifan

    Time frame: Up to 4 months

  3. Area under the plasma concentration time curve (AUC) of casdatifan

    Time frame: Up to 4 months

  4. Maximum Observed Plasma Concentration (Cmax) of casdatifan

    Time frame: Up to 4 months

06

Study locations

24 of 25 sites recruiting
  • Research Site
    Birmingham, Alabama 35294, United States
    Recruiting
  • Research Site
    San Diego, California 92093, United States
    Recruiting
  • Research Site
    Santa Monica, California 90404, United States
    Recruiting
  • Research Site
    Miami, Florida 33136, United States
    Recruiting
  • Research Site
    Atlanta, Georgia 30322-1013, United States
    Recruiting
  • Research Site
    Louisville, Kentucky 40202, United States
    Recruiting
  • Research Site
    New Orleans, Louisiana 70121, United States
    Recruiting
  • Research Site
    Baltimore, Maryland 21287, United States
    Recruiting
  • Research Site
    Boston, Massachusetts 02215, United States
    Recruiting
  • Research Site
    Detroit, Michigan 48201, United States
    Recruiting
  • Research Site
    Detroit, Michigan 48202, United States
    Recruiting
  • Research Site
    Omaha, Nebraska 68124, United States
    Recruiting
  • Research Site
    New York, New York 10029, United States
    Recruiting
  • Research Site
    New York, New York 10065, United States
    Recruiting
  • Research Site
    Cleveland, Ohio 44106, United States
    Recruiting
  • Research Site
    Cleveland, Ohio 44195, United States
    Recruiting
  • Research Site
    Pittsburgh, Pennsylvania 15232, United States
    Recruiting
  • Research Site
    Nashville, Tennessee 37203, United States
    Recruiting
  • Research Site
    Nashville, Tennessee 37240, United States
    Recruiting
  • Research Site
    San Antonio, Texas 78229, United States
    Recruiting
  • Research Site
    Camperdown, Australia
    Not yet recruiting
  • Research Site
    Melbourne, Australia
    Recruiting
  • Research Site
    Sydney, Australia
    Recruiting
  • Research Site
    Seoul, South Korea
    Recruiting
  • Research Site
    Barcelona, Spain
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

08

Registry details

Key details

Study ID
NCT05536141
Lead sponsor
Arcus Biosciences, Inc.
Responsible party
Sponsor
First posted
Sep 10, 2022
Start date
Oct 26, 2022
Primary completion
Mar 2029 (estimated)
Completion
Mar 2029 (estimated)
Last update
Aug 31, 2026

Study contacts

Medical Director
Contact
ClinicalTrialInquiry@arcusbio.com
+1-510-462-3330
Medical Director
study director · Arcus Biosciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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