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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05536141
Registration number
NCT05536141
Ethics application status
Date submitted
7/09/2022
Date registered
10/09/2022
Date last updated
29/06/2025
Titles & IDs
Public title
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
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Scientific title
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
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Secondary ID [1]
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2024-519142-70-00
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Secondary ID [2]
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ARC-20
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Universal Trial Number (UTN)
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Trial acronym
ARC-20
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Clear Cell Renal Cell Carcinoma
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Solid Tumors
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - casdatifan
Treatment: Drugs - Cabozantinib
Treatment: Drugs - Zimberelimab
Experimental: Dose Escalation Cohort 1 - Participants will receive casdatifan orally once daily
Experimental: Dose Escalation Cohort 2 - Participants will receive casdatifan orally once daily
Experimental: Dose Escalation Cohort 3 - Participants will receive casdatifan orally twice daily
Experimental: Dose Escalation Cohort 4 - Participants will receive casdatifan orally once daily
Experimental: Dose Escalation Cohort 5 - Participants will receive casdatifan orally once daily
Experimental: Dose Expansion Cohort 1 - Participants will receive casdatifan orally
Experimental: Dose Expansion Cohort 2 - Participants will receive casdatifan orally
Experimental: Dose Expansion Cohort 3 - Participants will receive casdatifan orally
Experimental: Dose Expansion Cohort 4 - Participants will receive casdatifan orally with with cabozantinib orally
Experimental: Dose Expansion Cohort 5 - Participants will receive casdatifan orally
Experimental: Dose Expansion Cohort 6 - Participants will receive casdatifan orally
Experimental: Dose Expansion Cohort 7 - Participants will receive casdatifan orally with zimberelimab infusion
Experimental: Dose Expansion Cohort 8 - Participants will receive casdatifan orally
Treatment: Drugs: casdatifan
Administered as specified in the treatment arm
Treatment: Drugs: Cabozantinib
Administered as specified in the treatment arm
Treatment: Drugs: Zimberelimab
Administered as specified in the treatment arm
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with dose limiting toxicities (DLTs)
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Assessment method [1]
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Timepoint [1]
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Up to 4 months
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Primary outcome [2]
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Number of participants with adverse events (AEs)
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Assessment method [2]
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Timepoint [2]
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Up to 4 months
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Secondary outcome [1]
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Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Assessment method [1]
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Timepoint [1]
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Up to 4 months
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Secondary outcome [2]
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Plasma concentration of casdatifan
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Assessment method [2]
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Timepoint [2]
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Up to 4 months
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Secondary outcome [3]
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Area under the plasma concentration time curve (AUC) of casdatifan
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Assessment method [3]
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Timepoint [3]
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Up to 4 months
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Secondary outcome [4]
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Maximum Observed Plasma Concentration (Cmax) of casdatifan
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Assessment method [4]
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Timepoint [4]
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Up to 4 months
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Eligibility
Key inclusion criteria
Key
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)-2a 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/10/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2027
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Actual
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Sample size
Target
302
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Ashford Cancer Centre Research/ICON - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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California
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Florida
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Georgia
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Country [5]
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United States of America
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Kentucky
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Country [6]
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United States of America
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Louisiana
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Country [7]
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United States of America
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Maryland
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Massachusetts
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Country [9]
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Michigan
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Country [10]
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United States of America
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State/province [10]
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Nebraska
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Country [11]
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United States of America
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New York
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Country [12]
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State/province [12]
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Ohio
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Country [13]
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Pennsylvania
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Country [14]
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State/province [14]
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Tennessee
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Country [15]
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United States of America
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State/province [15]
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Texas
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Country [16]
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Korea, Republic of
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State/province [16]
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Seoul
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Arcus Biosciences, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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 in participants with ccRCC in the dose expansion stage
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Trial website
https://clinicaltrials.gov/study/NCT05536141
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Arcus Biosciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Medical Director
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Address
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Country
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Phone
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+1-510-462-3330
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05536141
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