A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
NCT ID: NCT05536141
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
302 participants
INTERVENTIONAL
2022-10-26
2027-07-31
Brief Summary
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* 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 in participants with ccRCC in the dose expansion stage
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Cohort 1
Participants will receive casdatifan orally once daily
casdatifan
Administered as specified in the treatment arm
Dose Escalation Cohort 2
Participants will receive casdatifan orally once daily
casdatifan
Administered as specified in the treatment arm
Dose Escalation Cohort 3
Participants will receive casdatifan orally twice daily
casdatifan
Administered as specified in the treatment arm
Dose Escalation Cohort 4
Participants will receive casdatifan orally once daily
casdatifan
Administered as specified in the treatment arm
Dose Escalation Cohort 5
Participants will receive casdatifan orally once daily
casdatifan
Administered as specified in the treatment arm
Dose Expansion Cohort 1
Participants will receive casdatifan orally
casdatifan
Administered as specified in the treatment arm
Dose Expansion Cohort 2
Participants will receive casdatifan orally
casdatifan
Administered as specified in the treatment arm
Dose Expansion Cohort 3
Participants will receive casdatifan orally
casdatifan
Administered as specified in the treatment arm
Dose Expansion Cohort 4
Participants will receive casdatifan orally with with cabozantinib orally
casdatifan
Administered as specified in the treatment arm
Cabozantinib
Administered as specified in the treatment arm
Dose Expansion Cohort 5
Participants will receive casdatifan orally
casdatifan
Administered as specified in the treatment arm
Dose Expansion Cohort 6
Participants will receive casdatifan orally
casdatifan
Administered as specified in the treatment arm
Dose Expansion Cohort 7
Participants will receive casdatifan orally with zimberelimab infusion
casdatifan
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Dose Expansion Cohort 8
Participants will receive casdatifan orally
casdatifan
Administered as specified in the treatment arm
Interventions
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casdatifan
Administered as specified in the treatment arm
Cabozantinib
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
18 Years
ALL
No
Sponsors
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Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Arcus Biosciences
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California at San Diego
San Diego, California, United States
UCLA
Santa Monica, California, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Louisville Brown Cancer Center
Louisville, Kentucky, United States
Oschner Health
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Nebraska Cancer Specialists - Oncology Hematology West PC
Omaha, Nebraska, United States
Tisch Cancer Institute, Icahn Mount Sinai Hospital
New York, New York, United States
University Hospitals Cleveland Clinical
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Chris O'Brien Lifehouse
Camperdown, , Australia
Box Hill Hospital
Melbourne, , Australia
Ashford Cancer Centre Research/ICON
Sydney, , Australia
Macquarie University Hospital
Sydney, , Australia
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Related Links
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ARC-20 - Public website
Other Identifiers
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2024-519142-70-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARC-20
Identifier Type: -
Identifier Source: org_study_id
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