A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
ARC-20
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
2 other identifiers
interventional
362
4 countries
25
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 or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2022
Longer than P75 for phase_1
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedStudy Start
First participant enrolled
October 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
May 1, 2026
April 1, 2026
6.4 years
September 7, 2022
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with dose limiting toxicities (DLTs)
Up to 4 months
Number of participants with adverse events (AEs)
Up to 4 months
Secondary Outcomes (4)
Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to 4 months
Plasma concentration of casdatifan
Up to 4 months
Area under the plasma concentration time curve (AUC) of casdatifan
Up to 4 months
Maximum Observed Plasma Concentration (Cmax) of casdatifan
Up to 4 months
Study Arms (15)
Dose Escalation Cohort 1
EXPERIMENTALParticipants will receive casdatifan orally once daily
Dose Escalation Cohort 2
EXPERIMENTALParticipants will receive casdatifan orally once daily
Dose Escalation Cohort 3
EXPERIMENTALParticipants will receive casdatifan orally twice daily
Dose Escalation Cohort 4
EXPERIMENTALParticipants will receive casdatifan orally once daily
Dose Escalation Cohort 5
EXPERIMENTALParticipants will receive casdatifan orally once daily
Dose Expansion Cohort 1
EXPERIMENTALParticipants will receive casdatifan orally
Dose Expansion Cohort 2
EXPERIMENTALParticipants will receive casdatifan orally
Dose Expansion Cohort 3
EXPERIMENTALParticipants will receive casdatifan orally
Dose Expansion Cohort 4
EXPERIMENTALParticipants will receive casdatifan orally with with cabozantinib orally
Dose Expansion Cohort 5
EXPERIMENTALParticipants will receive casdatifan orally
Dose Expansion Cohort 6
EXPERIMENTALParticipants will receive casdatifan orally
Dose Expansion Cohort 7
EXPERIMENTALParticipants will receive casdatifan orally with zimberelimab infusion
Dose Expansion Cohort 8
EXPERIMENTALParticipants will receive casdatifan orally
Dose Expansion Cohort 9
EXPERIMENTALParticipants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion
Dose Expansion Cohort 10
EXPERIMENTALParticipants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion
Interventions
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Research Site
Birmingham, Alabama, 35294, United States
Research Site
San Diego, California, 92093, United States
Research Site
Santa Monica, California, 90404, United States
Research Site
Miami, Florida, 33136, United States
Research Site
Atlanta, Georgia, 30322-1013, United States
Research Site
Louisville, Kentucky, 40202, United States
Research Site
New Orleans, Louisiana, 70121, United States
Research Site
Baltimore, Maryland, 21287, United States
Research Site
Boston, Massachusetts, 02215, United States
Research Site
Detroit, Michigan, 48201, United States
Research Site
Detroit, Michigan, 48202, United States
Research Site
Omaha, Nebraska, 68124, United States
Research Site
New York, New York, 10029, United States
Research Site
New York, New York, 10065, United States
Research Site
Cleveland, Ohio, 44106, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Pittsburgh, Pennsylvania, 15232, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Nashville, Tennessee, 37240, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Camperdown, Australia
Research Site
Melbourne, Australia
Research Site
Sydney, Australia
Research Site
Seoul, South Korea
Research Site
Barcelona, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Arcus Biosciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2022
First Posted
September 10, 2022
Study Start
October 26, 2022
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
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.