Clear Cell Renal Cell CarcinomaPhase 1ARC-20NCT05536141
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
A Phase 1 study testing casdatifan, Cabozantinib and Zimberelimab in people with Clear Cell Renal Cell Carcinoma and Solid Tumors, run by Arcus Biosciences, Inc. at 25 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma, Solid Tumors
- What is being tested?
- casdatifan, Cabozantinib and Zimberelimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 26 Oct 2022to Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
25 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 4 countries
United States20 sites, 20 recruiting
- Recruiting
Research Site
Atlanta, Georgia, 30322-1013
- Recruiting
Research Site
Baltimore, Maryland, 21287
- Recruiting
Research Site
Birmingham, Alabama, 35294
- Recruiting
Research Site
Boston, Massachusetts, 02215
- Recruiting
Research Site
Cleveland, Ohio, 44106
- Recruiting
Research Site
Cleveland, Ohio, 44195
- Recruiting
Research Site
Detroit, Michigan, 48201
- Recruiting
Research Site
Detroit, Michigan, 48202
- Recruiting
Research Site
Louisville, Kentucky, 40202
- Recruiting
Research Site
Miami, Florida, 33136
- Recruiting
Research Site
Nashville, Tennessee, 37203
- Recruiting
Research Site
Nashville, Tennessee, 37240
- Recruiting
Research Site
New Orleans, Louisiana, 70121
- Recruiting
Research Site
New York, New York, 10029
- Recruiting
Research Site
New York, New York, 10065
- Recruiting
Research Site
Omaha, Nebraska, 68124
- Recruiting
Research Site
Pittsburgh, Pennsylvania, 15232
- Recruiting
Research Site
San Antonio, Texas, 78229
- Recruiting
Research Site
San Diego, California, 92093
- Recruiting
Research Site
Santa Monica, California, 90404
Australia3 sites, 3 recruiting
- Not yet recruiting
Research Site
Camperdown
- Recruiting
Research Site
Melbourne
- Recruiting
Research Site
Sydney
About this study
Official 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
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.
- Conditions
- Clear Cell Renal Cell Carcinoma, Solid Tumors
- Being tested
- casdatifan, Cabozantinib, Zimberelimab, Ipilimumab
- Keywords
- Clear Cell Renal Cell Carcinoma, AB521, Casdatifan, Kidney Cancer, Zimberelimab, AB122, Hif2a
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Erythrocytosis, Familial, 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
casdatifanDrug
Also called AB521
Administered as specified in the treatment arm
CabozantinibDrug
Administered as specified in the treatment arm
ZimberelimabDrug
Also called AB122
Administered as specified in the treatment arm
IpilimumabDrug
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort 1 | Experimental | Participants will receive casdatifan orally once daily Receives: Drug: casdatifan |
| Dose Escalation Cohort 2 | Experimental | Participants will receive casdatifan orally once daily Receives: Drug: casdatifan |
| Dose Escalation Cohort 3 | Experimental | Participants will receive casdatifan orally twice daily Receives: Drug: casdatifan |
| Dose Escalation Cohort 4 | Experimental | Participants will receive casdatifan orally once daily Receives: Drug: casdatifan |
| Dose Escalation Cohort 5 | Experimental | Participants will receive casdatifan orally once daily Receives: Drug: casdatifan |
| Dose Expansion Cohort 1 | Experimental | Participants will receive casdatifan orally Receives: Drug: casdatifan |
| Dose Expansion Cohort 2 | Experimental | Participants will receive casdatifan orally Receives: Drug: casdatifan |
| Dose Expansion Cohort 3 | Experimental | Participants will receive casdatifan orally Receives: Drug: casdatifan |
| Dose Expansion Cohort 4 | Experimental | Participants will receive casdatifan orally with with cabozantinib orally Receives: Drug: casdatifan; Drug: Cabozantinib |
| Dose Expansion Cohort 5 | Experimental | Participants will receive casdatifan orally Receives: Drug: casdatifan |
| Dose Expansion Cohort 6 | Experimental | Participants will receive casdatifan orally Receives: Drug: casdatifan |
| Dose Expansion Cohort 7 | Experimental | Participants will receive casdatifan orally with zimberelimab infusion Receives: Drug: casdatifan; Drug: Zimberelimab |
| Dose Expansion Cohort 8 | Experimental | Participants will receive casdatifan orally Receives: Drug: casdatifan |
| Dose Expansion Cohort 9 | Experimental | Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion Receives: Drug: casdatifan; Drug: Zimberelimab; Drug: Ipilimumab |
| Dose Expansion Cohort 10 | Experimental | Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion Receives: Drug: casdatifan; Drug: Zimberelimab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities (DLTs)
Measured: Up to 4 months
Number of participants with adverse events (AEs)
Measured: Up to 4 months
Secondary outcomes (4)
Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Up to 4 months
Plasma concentration of casdatifan
Measured: Up to 4 months
Area under the plasma concentration time curve (AUC) of casdatifan
Measured: Up to 4 months
Maximum Observed Plasma Concentration (Cmax) of casdatifan
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start26 Oct 2022
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536141
- Sponsor's protocol ID
- ARC-20
- Other IDs
- 2024-519142-70-00
- Acronym
- ARC-20
- Status last verified
- Apr 2026
- First submitted
- 7 Sep 2022
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05536141
- Acronym / sponsor ID
- ARC-20 / ARC-20
- Conditions
- Clear Cell Renal Cell Carcinoma, Solid Tumors
- Keywords
- Clear Cell Renal Cell Carcinoma, AB521, Casdatifan, Kidney Cancer, Zimberelimab, AB122, Hif2a
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort 1 | Experimental | Drug: casdatifanParticipants will receive casdatifan orally once daily |
| Dose Escalation Cohort 2 | Experimental | Drug: casdatifanParticipants will receive casdatifan orally once daily |
| Dose Escalation Cohort 3 | Experimental | Drug: casdatifanParticipants will receive casdatifan orally twice daily |
| Dose Escalation Cohort 4 | Experimental | Drug: casdatifanParticipants will receive casdatifan orally once daily |
| Dose Escalation Cohort 5 | Experimental | Drug: casdatifanParticipants will receive casdatifan orally once daily |
| Dose Expansion Cohort 1 | Experimental | Drug: casdatifanParticipants will receive casdatifan orally |
| Dose Expansion Cohort 2 | Experimental | Drug: casdatifanParticipants will receive casdatifan orally |
| Dose Expansion Cohort 3 | Experimental | Drug: casdatifanParticipants will receive casdatifan orally |
| Dose Expansion Cohort 4 | Experimental | Drug: casdatifan, Drug: CabozantinibParticipants will receive casdatifan orally with with cabozantinib orally |
| Dose Expansion Cohort 5 | Experimental | Drug: casdatifanParticipants will receive casdatifan orally |
| Dose Expansion Cohort 6 | Experimental | Drug: casdatifanParticipants will receive casdatifan orally |
| Dose Expansion Cohort 7 | Experimental | Drug: casdatifan, Drug: ZimberelimabParticipants will receive casdatifan orally with zimberelimab infusion |
| Dose Expansion Cohort 8 | Experimental | Drug: casdatifanParticipants will receive casdatifan orally |
| Dose Expansion Cohort 9 | Experimental | Drug: casdatifan, Drug: Zimberelimab, Drug: IpilimumabParticipants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion |
| Dose Expansion Cohort 10 | Experimental | Drug: casdatifan, Drug: Zimberelimab, Drug: IpilimumabParticipants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Histologically confirmed ccRCC
- Creatinine clearance ≥ 40 mL/min
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| casdatifanAlso: AB521Administered as specified in the treatment arm | Drug | Dose Escalation Cohort 1, Dose Escalation Cohort 2, Dose Escalation Cohort 3, Dose Escalation Cohort 4, Dose Escalation Cohort 5, Dose Expansion Cohort 1, Dose Expansion Cohort 10, Dose Expansion Cohort 2, Dose Expansion Cohort 3, Dose Expansion Cohort 4, Dose Expansion Cohort 5, Dose Expansion Cohort 6, Dose Expansion Cohort 7, Dose Expansion Cohort 8, Dose Expansion Cohort 9 |
| CabozantinibAdministered as specified in the treatment arm | Drug | Dose Expansion Cohort 4 |
| ZimberelimabAlso: AB122Administered as specified in the treatment arm | Drug | Dose Expansion Cohort 10, Dose Expansion Cohort 7, Dose Expansion Cohort 9 |
| IpilimumabAdministered as specified in the treatment arm | Drug | Dose Expansion Cohort 10, Dose Expansion Cohort 9 |
Primary outcome
Number of participants with dose limiting toxicities (DLTs)
Time frame: Up to 4 months
Number of participants with adverse events (AEs)
Time frame: Up to 4 months
4 secondary outcomes
Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 4 months
Plasma concentration of casdatifan
Time frame: Up to 4 months
Area under the plasma concentration time curve (AUC) of casdatifan
Time frame: Up to 4 months
Maximum Observed Plasma Concentration (Cmax) of casdatifan
Time frame: Up to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- ARC-20 - Public websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Arcus Biosciences
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing casdatifan, Cabozantinib and Zimberelimab in people with Clear Cell Renal Cell Carcinoma and Solid Tumors, run by Arcus Biosciences, Inc. at 25 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Australia, South Korea, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director (+1-510-462-3330, ClinicalTrialInquiry@arcusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities (DLTs) (time frame: Up to 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.