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 2026-11-13.
Sponsored by Arcus Biosciences, Inc. · Phase 1, Interventional, and Treatment
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Among 1,142 studies in Carcinoma, Renal Cell with a site in United States — 156 open to participants now, 280 under way, 26 of them phase 3. Carcinoma, Renal Cell · United States.
Among the 1,142 studies in Carcinoma, Renal Cell with a site in United States, this one is the 61st largest by planned enrollment of the 1,008 interventional ones that give a count, is one of 51 that started in 2022, is one of 342 in phase 1, reaches primary completion later than 229 of the 278 other live ones, and was the 966th registered.
2,038 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
Browse Carcinoma, Renal Cell studies →156 of the 1,142 studies in Carcinoma, Renal Cell with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
University of Oklahoma · Sites in United States
Ages 18–100 · Men only
Roswell Park Cancer Institute · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18–100
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 307 Carcinoma, Renal Cell studies recruiting now, 254 (83%) set no upper age limit and 18 (6%) stop at 75 or younger; 20 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,142 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 488 · Phase 2 529 · Phase 3 74 · Phase 4 10
First in 1990; this study’s year is marked. 51 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 512 is above the median of 43 across 1,565 interventional studies indexed under Carcinoma, Renal Cell.
Median enrollment 40 across the 1,008 interventional studies, 100 across the 87 observational. Of the 791 that completed or were terminated, 336 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
467 of 1,142 have an industry lead sponsor. The 10 most frequent:
Arcus Biosciences, Inc. is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Arcus Biosciences, Inc. has 3 studies filed under Carcinoma, Renal Cell — fewer than ten, so there is no comparison to draw.
98 of the studies in Carcinoma, Renal Cell with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT05678673Phase 3ExelixisStudy of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma | 2026-12-15 |
| NCT03592472Phase 3Xynomic Pharmaceuticals, Inc.A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV) | 2026-12-30 |
| NCT03873402Phase 3Bristol-Myers SquibbA Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer | 2027-03-11 |
| NCT05863351Phase 3ECOG-ACRIN Cancer Research GroupFocused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study | 2027-08-31 |
Add all 98 to your calendar (.ics) → With an account.
Among the 1,142 studies in Carcinoma, Renal Cell with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the safety and tolerability of:
The criteria were revised on the registry on Nov 13, 2026. See what changed
Key Inclusion Criteria:
Disease-specific criteria for dose escalation:
Disease-specific criteria for dose-expansion:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive casdatifan orally once daily
Drug: Casdatifan
Participants will receive casdatifan orally once daily
Drug: Casdatifan
Participants will receive casdatifan orally twice daily
Drug: Casdatifan
Participants will receive casdatifan orally once daily
Drug: Casdatifan
Participants will receive casdatifan orally once daily
Drug: Casdatifan
Participants will receive casdatifan orally
Drug: Casdatifan
Participants will receive casdatifan orally
Drug: Casdatifan
Participants will receive casdatifan orally
Drug: Casdatifan
Participants will receive casdatifan orally with with cabozantinib orally
Drug: Casdatifan · Drug: Cabozantinib
Participants will receive casdatifan orally
Drug: Casdatifan
Participants will receive casdatifan orally
Drug: Casdatifan
Participants will receive casdatifan orally with zimberelimab infusion
Drug: Casdatifan · Drug: Zimberelimab
Participants will receive casdatifan orally
Drug: Casdatifan
Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion
Drug: Casdatifan · Drug: Zimberelimab · Drug: Ipilimumab
Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion
Drug: Casdatifan · Drug: Zimberelimab · Drug: Ipilimumab
Participants will receive casdatifan orally with tivozanib orally or tivozanib orally only.
Drug: Casdatifan · Drug: Tivozanib
Participants will receive casdatifan orally with ivonescimab infusion.
Drug: Casdatifan · Drug: Ivonescimab
Participants will receive casdatifan orally with zimberelimab infusion and axitinib orally.
Drug: Casdatifan · Drug: Zimberelimab · Drug: Axitinib
Administered as specified in the treatment arm
Also known as: AB521
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Also known as: AB122
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
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
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
Duration of Response as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 4 months
Progression-free survival as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 4 months
Overall survival
Time frame: Up to 4 months
Area under the plasma concentration time curve (AUC) of casdatifan in combination with tivozanib
Time frame: Up to 4 months
Maximum Observed Plasma Concentration (Cmax) of casdatifan in combination with tivozanib
Time frame: Up to 4 months
Area under the plasma concentration time curve (AUC) of casdatifan in combination with ivonescimab
Time frame: Up to 4 months
Maximum Observed Plasma Concentration (Cmax) of casdatifan in combination with ivonescimab
Time frame: Up to 4 months
Percentage of patients who are ADA-positive and ADA-negative against ivonescimab
Time frame: Up to 4 months
Area under the plasma concentration time curve (AUC) of casdatifan in combination with zimberelimab and axitinib
Time frame: Up to 4 months
Maximum Observed Plasma Concentration (Cmax) of casdatifan in combination with zimberelimab and axitinib
Time frame: Up to 4 months
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, Statistical analysis plan, Clinical study report
Data sharing details ↗ · trials.arcusbio.com
Started Oct 2022 (actual). Primary completion is estimated for Mar 2029, 77 months after the start.
Of 138 industry-sponsored phase 1 interventional studies under Carcinoma, Renal Cell, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 63. This study's planned 77 months is above that.
Counting every sponsor, half of 219 studies reached it within 50 months; a quarter within 32 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Casdatifan