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Casdatifan

Phase 3

Metastatic Clear Cell Renal Cell Carcinoma | Small molecule | Oncology |Arcus Biosciences, Inc.|Last Updated: Sep 4, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment720

FDA Designations

No designations recorded

Clinical trial landscape

Casdatifan · 9 trials · 11 indications

Phase 3 1Phase 2 1Phase 1 6Early Phase 1 1
NCT07011719Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell CarcinomaMetastatic Clear Cell Renal Cell Carcinoma
RECRUITING720 Analytics
PHASE3RECRUITING
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma
NCT07011719720
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Study Endpoints

Primary Endpoints

Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
up to approximately 33 months
Tumor Size Reduction Rate
Disease assessment will occur at pre-surgery visit week 11 ± 2 weeks.

Tumor size reduction rate is defined as the proportion of participants who achieve any decrease in the maximal dimension of the primary tumor.

Area under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t)
Up to 10 days post-dose
Area under the concentration time curve from time 0 extrapolated to infinity of casdatifan in plasma (AUC0-inf)
Up to 10 days post-dose
Maximum observed concentration of casdatifan in plasma (Cmax)
Up to 10 days post-dose
Maximum observed concentration for casdatifan
Up to 168 hours post each dose
Area under the concentration-time curve for casdatifan
Up to 168 hours post each dose
Area Under the Plasma Drug Concentration-Time Curve (AUC) for casdatifan
Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3
Maximum Concentration (Cmax) in Plasma for casdatifan
Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3
Time to Maximum Concentration (Tmax) in Plasma for casdatifan
Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3
Area Under the Plasma Drug Concentration-Time Curve (AUC)
Predose, Up to 168 hours postdose
Maximum Concentration (Cmax)
Predose, Up to 168 hours postdose
Time to Maximum Concentration (Tmax)
Predose, Up to 168 hours postdose
Terminal Half-Life Time (t1/2)
Predose, Up to 168 hours postdose
Apparent Total Plasma Clearance (CL/F)
Predose, Up to 168 hours postdose
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
Predose, Up to 168 hours postdose
Number of participants with dose limiting toxicities (DLTs)
Up to 4 months
Number of participants with adverse events (AEs)
Up to 4 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Up to 21.5 Weeks
Number of Participants With Abnormal Changes From Baseline in Laboratory Parameter Values
Baseline; Up to 21.5 Weeks
Number of Participants With Abnormal Changes from Baseline in Vital Sign Values
Baseline; Up to 21.5 Weeks
Maximum Observed Plasma Concentration (Cmax) of casdatifan
multiple timepoints up to approximately 21.5 Weeks
Area Under the Plasma Concentration Time Curve From Hour 0 to the Last Sample With Measurable Plasma Concentrations (AUClast) of casdatifan
multiple timepoints up to approximately 21.5 Weeks
Time of Occurrence of Cmax (tmax) of casdatifan
multiple timepoints up to approximately 21.5 Weeks
Apparent Terminal Elimination Rate Constant (λz) of casdatifan
multiple timepoints up to approximately 21.5 Weeks
Terminal Half-Life (t1/2) of casdatifan
multiple timepoints up to approximately 21.5 Weeks
Area Under the Plasma Concentration Time Curve From Hour 0 to Infinity (AUCinf) of casdatifan
multiple timepoints up to approximately 21.5 Weeks
Apparent Volume of Distribution of casdatifan
multiple timepoints up to approximately 21.5 Weeks
Apparent Total Body Clearance of casdatifan
multiple timepoints up to approximately 21.5 Weeks
To determine the change in expression of predefined HIF2-regulated target genes in metastatic tumor tissue following casdatifan therapy in a refractory ccRCC population.
1 year

A serial biopsy design, incorporating biopsies at baseline, on-treatment, and disease progression, enables longitudinal evaluation of the HIF-2α transcriptional program and characterization of adaptive or resistance-associated gene expression changes emerging during therapy.

Secondary Endpoints

Overall Survival (OS)
up to approximately 64 months
Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
up to approximately 33 months
Duration of Response (DOR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
up to approximately 33 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A (Experimental Arm)EXPERIMENTALCasdatifan and cabozantinib taken orally
Arm B (Comparator Arm)PLACEBO_COMPARATORPlacebo and cabozantinib taken orally
Group A: CasdatifanEXPERIMENTAL16 participants will be enrolled and will complete the following: * Baseline visit * Cycle 1 through 3 (21 day cycles): --Days 1 - 21: Predetermined dose of Casdatifan 1x daily * standard of care nephrectomy * Follow up for up to 3 years
Group B: Casdatifan + ZimberelimabEXPERIMENTAL* 16 participants will be enrolled and will complete the following: * Baseline visit * Cycle 1 through 3 (21 day cycles): * Days 1 - 21: Predetermined dose of Casdatifan 1x daily * Day 1: Predetermined dose of Zimberelimab * Standard of care nephrectomy * Follow up for up to 3 years
Group 1: Moderate Hepatic ImpairmentEXPERIMENTALAdministered as specified in the treatment arm.
Group 2: Healthy Control ParticipantsEXPERIMENTALAdministered as specified in the treatment arm.
Treatment AEXPERIMENTALParticipants will receive 4 X 25 mg tablets of casdatifan.
Treatment BEXPERIMENTALParticipants will receive 1 X 100 mg tablets of casdatifan.
Treatment CEXPERIMENTALParticipants will receive 4 X 25 mg tablets of casdatifan under fed conditions.
Casdatifan-Itraconazole-PhenytoinEXPERIMENTALParticipants will receive casdatifan, itraconazole, and phenytoin.
Casdatifan - Sequence ABCEXPERIMENTALParticipants will sequentially receive casdatifan capsules fasted (Treatment A), followed by casdatifan tablets fasted (Treatment B), followed by casdatifan tablets fed (Treatment C)
Casdatifan - Sequence BCAEXPERIMENTALParticipants will sequentially receive Treatment B, followed by Treatment C, then Treatment A
Casdatifan - Sequence CABEXPERIMENTALParticipants will sequentially receive Treatment C, followed by Treatment A, then Treatment B
Dose Escalation Cohort 1EXPERIMENTALParticipants will receive casdatifan orally once daily
Dose Escalation Cohort 2EXPERIMENTALParticipants will receive casdatifan orally once daily
Dose Escalation Cohort 3EXPERIMENTALParticipants will receive casdatifan orally twice daily
Dose Escalation Cohort 4EXPERIMENTALParticipants will receive casdatifan orally once daily
Dose Escalation Cohort 5EXPERIMENTALParticipants will receive casdatifan orally once daily
Dose Expansion Cohort 1EXPERIMENTALParticipants will receive casdatifan orally
Dose Expansion Cohort 2EXPERIMENTALParticipants will receive casdatifan orally
Dose Expansion Cohort 3EXPERIMENTALParticipants will receive casdatifan orally
Dose Expansion Cohort 4EXPERIMENTALParticipants will receive casdatifan orally with with cabozantinib orally
Dose Expansion Cohort 5EXPERIMENTALParticipants will receive casdatifan orally
Dose Expansion Cohort 6EXPERIMENTALParticipants will receive casdatifan orally
Dose Expansion Cohort 7EXPERIMENTALParticipants will receive casdatifan orally with zimberelimab infusion
Dose Expansion Cohort 8EXPERIMENTALParticipants will receive casdatifan orally
Dose Expansion Cohort 9EXPERIMENTALParticipants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion
Dose Expansion Cohort 10EXPERIMENTALParticipants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion
SAD-casdatifan Dose 1EXPERIMENTALParticipants will receive "Dose 1" of casdatifan orally with water under fasting conditions.
SAD-casdatifan Dose 2EXPERIMENTALParticipants will receive "Dose 2" of casdatifan orally with water under fasting conditions.
SAD-casdatifan Dose 3EXPERIMENTALParticipants will receive "Dose 3" of casdatifan orally with water under fasting conditions.
SAD-casdatifan Dose 4EXPERIMENTALParticipants will receive "Dose 4" of casdatifan orally with water under fasting conditions.
SAD-PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo orally with water under fasting conditions.
MAD-casdatifan Dose 1EXPERIMENTALParticipants will receive "Dose 1" of casdatifan orally with water under fasting conditions.
MAD-casdatifan Dose 2EXPERIMENTALParticipants will receive "Dose 2" of casdatifan orally with water under fasting conditions.
MAD-PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo orally with water under fasting conditions.
DDI-casdatifan Dose + MidazolamEXPERIMENTALParticipants will receive highest safe dose level of casdatifan from MAD and midazolam orally with water under fasting conditions
CasdatifanEXPERIMENTALCasdatifan will be taken orally at a fixed dose of 100 mg once daily, with or without food, on a continuous schedule beginning on Cycle 1, Day 1.

Interventions

NameTypeDescription
CasdatifanDRUGAdministered as specified in the treatment arm
CabozantinibDRUGAdministered as specified in the treatment arm
PlaceboDRUGAdministered as specified in the treatment arm
ZimberelimabDRUGmonoclonal antibody, multi-dose vial, via intravenous (through the vein) infusion, per protocol.
ItraconazoleDRUGAdministered as multiple doses in treatment Period 2
PhenytoinDRUGAdministered as multiple doses in treatment Period 3
IpilimumabDRUGAdministered as specified in the treatment arm
MidazolamDRUGSyrup solution
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites176

Inclusion Criteria: * Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component. * A Karnofsky Performance Status (KPS) score ≥ 80% * At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not w...

Countries:United StatesArgentinaAustraliaCanadaCzechiaFranceGermanyItalyJapanNetherlandsNew ZealandPolandRomaniaSouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 4, 2026NCT07751250Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 2, 2026NCT07011719lastUpdatePostDate: changed
LOWSep 2, 2026NCT07011719lastUpdatePostDate: changed
LOWSep 2, 2026NCT07011719lastUpdatePostDate: changed
LOWAug 31, 2026NCT05536141lastUpdatePostDate: changed
LOWAug 31, 2026NCT05536141lastUpdatePostDate: changed
LOWAug 20, 2026NCT07748988lastUpdatePostDate: changed
LOWAug 20, 2026NCT07748988lastUpdatePostDate: changed
LOWAug 20, 2026NCT07748988lastUpdatePostDate: changed
LOWAug 20, 2026NCT07748988lastUpdatePostDate: changed
HIGHAug 14, 2026NCT07641881Status: RECRUITING → COMPLETED
HIGHAug 14, 2026NCT07641881Status: RECRUITING → COMPLETED
HIGHAug 14, 2026NCT07641881Status: RECRUITING → COMPLETED
LOWAug 7, 2026NCT07751250NEW_TRIAL: changed
LOWAug 7, 2026NCT07751250NEW_TRIAL: changed
LOWAug 6, 2026NCT07748988NEW_TRIAL: changed
LOWAug 6, 2026NCT07748988NEW_TRIAL: changed
LOWJul 31, 2026NCT07011719lastUpdatePostDate: changed
LOWJul 31, 2026NCT07011719lastUpdatePostDate: changed
LOWJul 29, 2026NCT05536141lastUpdatePostDate: changed

Frequently asked questions about Casdatifan

What is Casdatifan used for?

Casdatifan is an investigational small molecule being studied for the treatment of clear cell renal cell carcinoma, renal cell carcinoma, refractory renal cell carcinoma, and metastatic clear cell renal cell carcinoma. It is also being evaluated in healthy participants. The drug is in Phase 3 clinical development for advanced clear cell renal cell carcinoma.

Who makes Casdatifan?

Casdatifan is being developed by Arcus Biosciences, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol RCUS. The company is conducting clinical trials of Casdatifan in renal cell carcinoma and other solid tumors.

What phase is Casdatifan in?

Casdatifan is in Phase 3 clinical development. A Phase 3 trial, NCT07011719, is recruiting patients with advanced or metastatic clear cell renal cell carcinoma. The drug is investigational and has not been approved by the FDA.

What clinical trials is Casdatifan in?

Casdatifan is being studied in four clinical trials. NCT05536141 is a Phase 1 trial in renal cell carcinoma and solid tumors. NCT07011719 is a Phase 3 trial in advanced clear cell renal cell carcinoma. NCT07397611 is a Phase 2 neoadjuvant trial in renal cell carcinoma. NCT07748988 is an early Phase 1 pilot study in refractory renal cell carcinoma.

Is Casdatifan being tested in combination with other drugs?

Yes, Casdatifan is being studied in combination with cabozantinib in a Phase 3 trial, NCT07011719, for advanced clear cell renal cell carcinoma. This trial compares casdatifan plus cabozantinib against placebo plus cabozantinib. The study is recruiting patients aged 18 years and older.

What is the Phase 3 trial of Casdatifan studying?

The Phase 3 trial, NCT07011719, is studying casdatifan and cabozantinib versus placebo and cabozantinib in patients with advanced or metastatic clear cell renal cell carcinoma. This randomized, double-blind, placebo-controlled trial has an enrollment target of 720 participants and is recruiting across multiple countries including the United States.