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casdatifan

Generic: Casdatifan

casdatifan: sourced relationships with 1 company · 10 clinical trials tracked.

casdatifan evidence translation

What we can confirm

What it means

Source-backed records connect casdatifan to RCUS; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could casdatifan → RCUS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence7 indications · 3 study sponsors
Dated Pipeline Records (1)
CompanyDated record stage
Arcus Biosciences, Inc. (RCUS)
owner · Reported 2026-02-25 · Current development: unknownSource
Clear Cell Renal Cell Carcinoma; Healthy Participants; Metas…
Phase 3
Clinical Trial Registry Records (10)

A Pilot Study of HIF-Mediated Gene Expression Changes in Casdatifan-Treated Refractory Renal Cell Carcinoma

NCT07748988Registry updated 2026-09-25·Phase 1
Recruiting

Primary endpoint: To determine the change in expression of predefined HIF2-regulated target genes in metastatic tumor tissue following casdatifan therapy in a refractory ccRCC population.

Interventionalopen12 targetStarted 2026-09Completion 2031-011 site · United StatesVanderbilt-Ingram Cancer Center

A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics of Casdatifan (AB521) in Participants With Moderate Hepatic Impairment Compared to Healthy Matched Participants

NCT07751250Registry updated 2026-09-04·Phase 1·RCUS
Recruiting

Primary endpoint: Area under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t)

Interventionalopen16 targetStarted 2026-08Completion 2027-051 site · United StatesArcus Biosciences, Inc.

A Phase 1, Open-Label, Randomized, Single-Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Pharmacokinetic Study to Evaluate the Bioequivalence of Two Casdatifan (AB521) Tablet Strengths and Food Effect in Healthy Adult Participants

NCT07641881Registry updated 2026-08-13·Phase 1·RCUS
Completed

Primary endpoint: Maximum observed concentration for casdatifan

InterventionalRandomizedopen24 enrolledStarted 2026-05Completion 2026-081 site · United StatesArcus Biosciences, Inc.

ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC)

NCT07293351Registry updated 2026-09-23·Phase 1/Phase 2·BMY
Recruiting

Primary endpoint: Number of participants with adverse events (AEs)

InterventionalRandomizedopen474 targetStarted 2026-03Completion 2031-1195 sites · Argentina, Australia, Canada, Chile…Bristol-Myers Squibb

PRE-surgical NEOadjuvant Sandwich Immunotherapy With HIF inhibiTion in Renal Cell Carcinoma (PRENEOSHIFT-RCC)

NCT07397611Registry updated 2026-03-20·Phase 2
Recruiting

Primary endpoint: Tumor Size Reduction Rate

InterventionalRandomizedopen32 targetStarted 2026-03Completion 2029-093 sites · United StatesDana-Farber Cancer Institute

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

NCT07011719Registry updated 2026-09-29·Phase 3·RCUS
Recruiting

Primary endpoint: Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1

InterventionalRandomizedquadruple720 targetStarted 2025-09Completion 2030-12183 sites · Argentina, Australia, Canada, Czechia…Arcus Biosciences, Inc.

A Phase Ib/III Randomized, Multicenter, Global Study of Volrustomig Plus Casdatifan or Volrustomig Monotherapy Versus Nivolumab Plus Ipilimumab as First-line Treatment for Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

NCT07000149Registry updated 2026-08-03·Phase 1·AZN
Active, not recruiting

Primary endpoint: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

InterventionalRandomizedopen9 enrolledStarted 2025-07Completion 2027-013 sites · Australia, South KoreaAstraZeneca

A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of Casdatifan With Itraconazole (Strong CYP3A4 Inhibitor) and Phenytoin (Strong CYP3A4 Inducer) in Healthy Adult Participants

NCT06919991Registry updated 2025-11-13·Phase 1·RCUS
Completed

Primary endpoint: Area Under the Plasma Drug Concentration-Time Curve (AUC) for casdatifan

Interventionalopen14 enrolledStarted 2025-05Completion 2025-101 site · United StatesArcus Biosciences, Inc.

A Phase 1b/2 Dose-finding and Expansion Study Evaluating the Safety and Efficacy of Zanzalintinib (XL092) Combined With Either AB521 or AB521 Plus Nivolumab in Subjects With Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors.

NCT06191796Registry updated 2025-06-12·Phase 1·EXEL
Terminated

Primary endpoint: Dose-finding Stage: Number of participants with dose-limiting toxicities (DLTs)

Interventionalopen25 targetStarted 2024-01Completion 2025-0514 sites · United StatesExelixis

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

NCT05536141Registry updated 2026-10-05·Phase 1·RCUS
Recruiting

Primary endpoint: Number of participants with dose limiting toxicities (DLTs)

Interventionalopen362 targetStarted 2022-10Completion 2029-0325 sites · Australia, South Korea, Spain, United StatesArcus Biosciences, Inc.

Frequently asked questions

Which companies have sourced relationships with casdatifan?

casdatifan has dated SEC/FDA relationship records for Arcus Biosciences, Inc..

How many clinical trials involve casdatifan?

BioSniper tracks 10 clinical trials involving casdatifan.