Casdatifan

DRUG13 trials

Sponsors

Arcus Biosciences Inc., Arcus Biosciences, Inc., AstraZeneca, Pfizer, Bristol-Myers Squibb

Conditions

Advanced Clear Cell Renal Cell CarcinomaAdvanced Renal Cell CarcinomaAdvanced Renal Cell Carcinoma (RCC)Advanced or Metastatic Renal Cell CarcinomaCarcinoma, Renal CellCarcinoma, Renal Cell MetastasisCarcinoma, Renal Cell, AdvancedClear Cell Renal Cell Carcinoma

Early Phase 1

Pilot Study of Casdatifan-Treated Refractory Renal Cell Carcinoma

Not yet recruitingNCT07748988

Vanderbilt-Ingram Cancer CenterRefractory Renal Cell Carcinoma

Start: 2029-07-01End: 2031-01-01Target: 12Updated: 2026-08-19

Phase 1

Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile With Oral AB521 in Healthy Volunteers

CompletedNCT05117554

Arcus Biosciences, Inc.Healthy Participants

Start: 2021-11-09End: 2023-02-17Updated: 2024-10-17

A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors

RecruitingNCT05536141

Arcus Biosciences, Inc.Clear Cell Renal Cell Carcinoma, Solid Tumors

Start: 2022-10-26End: 2029-03-01Target: 362Updated: 2026-08-31

A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers

CompletedNCT05999513

Arcus Biosciences, Inc.Healthy Participants

Start: 2023-08-21End: 2023-10-31Updated: 2024-10-17

Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)

CompletedNCT06919991

Arcus Biosciences, Inc.Healthy Participants

Start: 2025-05-02End: 2025-10-18Updated: 2025-11-13

A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC

Active, not recruitingNCT07000149

AstraZenecaAdvanced Clear Cell Renal Cell Carcinoma

Start: 2025-07-28End: 2027-01-29Updated: 2026-08-03

Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

RecruitingNCT07227415

PfizerAdvanced or Metastatic Renal Cell Carcinoma, Advanced Renal Cell Carcinoma, Carcinoma, Renal Cell +10

Start: 2026-02-10End: 2028-11-01Target: 224Updated: 2026-09-17

A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)

RecruitingNCT07293351

Bristol-Myers SquibbAdvanced Renal Cell Carcinoma (RCC)

Start: 2026-03-26End: 2031-11-26Target: 474Updated: 2026-09-14

A Bioequivalence Study Between Two Casdatifan Tablet Strengths and Food Effect Study of Casdatifan in Healthy Adult Participants

CompletedNCT07641881

Arcus Biosciences, Inc.Healthy Participants

Start: 2026-05-29End: 2026-08-07Updated: 2026-08-13

Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function

RecruitingNCT07751250

Arcus Biosciences, Inc.Healthy Participants, Hepatic Impairment

Start: 2026-08-14End: 2027-05-01Target: 16Updated: 2026-09-04

Phase 2

Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC

RecruitingNCT07397611

Dana-Farber Cancer InstituteKidney Cancer, Kidney Neoplasm, Renal Carcinoma +1

Start: 2026-03-09End: 2029-09-30Target: 32Updated: 2026-03-20

Phase 3

Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

RecruitingNCT07011719

Arcus Biosciences, Inc.Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma

Start: 2025-09-08End: 2030-12-01Target: 720Updated: 2026-09-02

Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

RecruitingCTIS2024-515023-11-00

Arcus Biosciences Inc.Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma

Start: 2026-01-22Target: 308Updated: 2026-01-14

Related Papers

88 PEAK-1 (NCT07011719): A Randomized, Double-Blind, Active-Control Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients with Advanced Clear Cell Renal Cell Carcinoma

The Oncologist2026-09-01

20 PF-08634404 (SSGJ-707), a Tetravalent PD-1/VEGF Bispecific Antibody for the Treatment of Renal Cell Carcinoma (NCT07227415)

The Oncologist2026-09-01

3 Safety Profile of Casdatifan Monotherapy in Patients with Clear Cell Renal Cell Carcinoma: Pooled Analysis of the ARC-20 Study (NCT05536141)

The Oncologist2026-09-01

Casdatifan shows durable response linked to HIF-2α biology in kidney cancer

Nature2026-07-01

Discovery of Casdatifan, Part II: A Potent and Orally Bioavailable Inhibitor of Hypoxia Inducible Factor-2α.

2026-06-05

PEAK-1: A randomized, double-blind, active-control, multicenter phase 3 trial of casdatifan and cabozantinib versus placebo and cabozantinib in patients with advanced clear cell renal cell carcinoma.

Journal of Clinical Oncology2026-05-28

Abstract 7898: Clinical benefit of the HIF-2α inhibitor casdatifan (Cas) across molecular subtypes in clear cell renal cell carcinoma (ccRCC) patients from the ARC-20 Clinical Study

Cancer Research2026-04-03

Abstract PR006: Evidence for the involvement of HIF-2α biology in the clinical efficacy of casdatifan, a novel HIF-2α inhibitor, in clear cell renal cell carcinoma (ccRCC)

Cancer Research2026-03-13

Abstract A023: Erythropoietin (EPO) is a Pharmacodynamic Biomarker for Systemic HIF-2α Inhibition that Correlates with the Clinical Activity of Casdatifan

Molecular Cancer Therapeutics2025-10-22

2Combination casdatifan plus cabozantinib in previously treated patients with clear cell renal cell carcinoma: results from an expansion cohort of ARC-20 (NCT05536141)

The Oncologist2025-10-01

Pharmacokinetics, pharmacodynamics and safety of casdatifan, a novel hypoxia‐inducible factor‐2α inhibitor, in healthy participants

British Journal of Clinical Pharmacology2025-07-271 citations

Combination casdatifan plus cabozantinib expansion cohort of phase 1 ARC-20 study in previously treated patients with clear cell renal cell carcinoma.

Journal of Clinical Oncology2025-05-28

Population Plasma and Urine Pharmacokinetic Data and Modelling of Casdatifan Supports Administration to Participants with Moderate Renal Impairment

2025-02-18

Casdatifan (Cas) monotherapy in patients (pts) with previously treated clear cell renal cell carcinoma (ccRCC): Safety, efficacy and subgroup analysis across multiple doses from ARC-20, a phase 1 open-label study.

Journal of Clinical Oncology2025-02-102 citations

Abstract A012: Discovery and characterization of Casdatifan (AB521), a clinical-stage, potent, and selective Hypoxia-Inducible Factor (HIF)-2α inhibitor

Molecular Cancer Therapeutics2024-12-092 citations

56 Clinical Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship Confirms Best-in-class Potential of Casdatifan (AB521), a Small Molecule Inhibitor of HIF-2α Being Developed in Renal Cancer

The Oncologist2024-08-051 citations

Abstract A002: Targeting hypoxia inducible factor (HIF)-2α with AB521, a novel and potent small molecule HIF-2α inhibitor, for the treatment of clear cell renal cell carcinoma

Cancer Research2023-08-152 citations

ARC-20: A phase 1 dose-escalation and dose-expansion study to investigate the safety, tolerability, and pharmacology of HIF-2α inhibitor AB521 monotherapy in patients with clear cell renal cell carcinoma and other solid tumors.

Journal of Clinical Oncology2023-06-013 citations